SPECIAL NOTICE
Q -- Aliquoting and shipping serum samples of selected breast cancer cases and controls in the Women�s Health Initiative (WHI)
- Notice Date
- 7/6/2023 5:58:36 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
- 75N91023Q00120
- 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
- 1.0�� �DESCRIPTION The Division of Cancer Epidemiology and Genetics (DCEG), plans to procure services, on a sole source basis, from the Fred Hutchinson Cancer Center�s WHI Clinical Coordinating Center, Mail Stop M3-B714, Seattle, WA �98109-1024. 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 Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals used in a wide range of industrial applications and consumer products. PFAS, including perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS), are highly persistent in the environment and in the human body, with nearly the entire U.S. population having detectable levels in their blood. As endocrine-disrupting chemicals with estrogenic properties, PFAS have been suggested to play a role in the development of breast cancer. However, epidemiologic evidence of the association between PFAS and breast cancer risk remains limited and inconclusive, with the majority of studies measuring PFAS in blood collected after cancer diagnosis. Recent work by the research team [U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB)] suggests that PFAS may be differentially associated with breast cancer subtypes, with positive associations observed between prediagnostic serum PFOS levels and hormone receptor-positive tumors, and possibly between PFOA and hormone receptor-negative tumors. However, this previous investigation had limited statistical power for the subtype-specific analyses and did not measure other commonly detected PFAS compounds beyond PFOS and PFOA.� DCEG proposes to conduct a nested case-control study within the Women�s Health Initiative (WHI) to investigate whether prediagnostic serum concentrations of seven PFAS, including PFOS and PFOA, are associated with risk of breast cancer among postmenopausal women, overall and by hormone receptor subtype. The WHI is a large prospective cohort study of more than 160,000 postmenopausal women aged 50-79?years who were recruited from 40 clinical centers across the United States between 1993 and 1998. In addition to completing self-administered questionnaires and interviews that collected detailed information on demographics and epidemiologic risk factors, participants also provided blood (serum) samples at the baseline visit. This investigation will utilize banked serum samples and accompanying covariate data available for selected participants in the WHI. The aliquoted serum samples from selected breast cancer cases and controls in the WHI will be used to measure concentrations of seven PFAS analytes. 2.1�� �OBJECTIVE The primary objective of this request is to select breast cancer cases and controls and aliquot and ship their serum samples for PFAS measurements as part of a nested case-control study investigating serum PFAS levels in relation to breast cancer risk within the WHI.� 3.0�� �SCOPE The Contractor shall select 1,950 breast cancer cases and controls plus 98 cancer-free participants for quality control (QC) from the WHI cohort, aliquot serum samples from the selected participants (total 2,048 samples), ship their serum samples to the testing laboratory, and prepare an analytic file that includes covariate data for the selected participants in the WHI. The NCI will coordinate with the Contractor regarding arrangements for shipping the samples to the laboratory that will perform the measurements of serum PFAS concentrations.� 4.0�� �PURCHASE ORDER REQUIREMENTS 4.1�� �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. The Contractor shall perform the following tasks. All data shall be coded and shall not contain any personally identifiable information (PII):� 4.1.1�� �Prepare a Specimen Selection and Aliquoting Plan by coordinating with the NCI Technical Point of Contact (TPOC) via email. 4.1.2�� �Select 2,048 cases, controls, and quality control samples by coordinating with NCI �Technical Point of Contact (TPOC). 4.1.3�� �Prepare one 250 �L aliquot of serum sample for each of the selected participants. 4.1.4�� �Document the aliquoted serum samples (in a MS Excel file) with the unique ID of each sample, the aliquoted volume, and the batching order. 4.1.5�� �Pack the serum aliquots in dry ice and other appropriate packing material and send them to the testing laboratory at the Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention (CDC, Atlanta, GA). 4.1.6�� �Prepare an analytic dataset that includes the serum PFAS concentrations and covariate data for each of the selected cases and controls. �All data shall be coded and shall not contain any personally identifiable information (PII). 4.1.7�� �Provide the NCI Technical Point of Contact (TPOC) with copies of the Excel sample documentation files and the accompanying covariate dataset. 4.1.8�� �The Contractor shall return samples to the storage facility. The Contractor will be responsible for the shipping fees. 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 period of performance shall be for 12 months from the date of award.� � 8.0�� �PLACE OF PERFORMANCE Services shall be provided at the Contractor�s facilities.� 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 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. � DELIVERABLE NO. �� �DELIVERABLE DESCRIPTION �� �FORMAT REQUIREMENTS�� �DUE DATE 1�� �Email: Sample specifications confirmation and coordination with NCI personnel�� �Confirmation of specifications via e-mail to the NCI TPOC and teleconference for coordination�� �10 days after award of contract 2�� �Spreadsheet: File of aliquoted serum samples, including sample ID, volume, batching order�� �Microsoft Excel file submitted via e-mail to the NCI TPOC�� �30 days after award of contract 3�� �Samples for PFAS analysis at testing laboratory �� �Samples shipped frozen on dry ice via overnight courier delivery�� �60-days after award of contract 4�� �Spreadsheet: Covariate dataset for selected cases and controls �� �Data file (in Excel, SAS, or Stata format) submitted to the NCI TPOC upon completion�� �30 days prior to the expiration of the period of performance 10.0�� �INSPECTION AND ACCEPTANCE CRITERIA 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 The Fred Hutchinson Cancer Center�s WHI Clinical Coordinating Center (Contractor) is the sole central coordinating center for the Women�s Health Initiative (WHI) study cohort and biorepository and is responsible for managing all the collected biospecimens and participant questionnaire data from the WHI. The Contractor is the only institution (vendor) that has access to and can provide the necessary biospecimen samples and questionnaire data for scientific investigations in the WHI study. As such, they are the only institution that can select and aliquot the serum samples and prepare the accompanying covariate dataset that will be used in this nested case-control study of serum PFAS concentrations and postmenopausal breast cancer risk within the WHI. It is essential to have careful records and inventory of the specimens and data. Specimens and data collected in the WHI are used by a large number of investigators for research projects, including previous investigations conducted by the NCI. 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: 75N91023Q00120 on all correspondence.
- Web Link
-
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- Record
- SN06738021-F 20230708/230706230045 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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