SPECIAL NOTICE
Q -- Procurement of services to aliquot serum samples among selected participants in the Multiethnic Cohort Study (MEC).
- Notice Date
- 8/17/2021 10:13:43 AM
- Notice Type
- Special Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NIH NCI ROCKVILLE MD 20852 USA
- ZIP Code
- 20852
- Solicitation Number
- 75N91021Q00223
- Response Due
- 8/23/2021 9:00:00 AM
- Archive Date
- 09/07/2021
- 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 and Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB) intends to procure laboratory testing services on a sole source basis from University of Hawaii Systems (University of Hawaii at Manoa) located at 2425 Campus Rd Sinclair RM 1, Honolulu, Hawaii, 96822, UNITED STATES. 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 The 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) is conducting an investigation within the Multiethnic Cohort (MEC), a large and diverse prospective cohort study consisting of more than 215,000 men and women aged 45-75 years at baseline (1993-1996) from different racial/ethnic groups (African Americans, 16% of participants; Japanese Americans, 26%; Latinos, 22%; Native Hawaiians, 6%; and whites, 23%) living in Hawaii and California. The prospective MEC biospecimen sub-cohort was established from 2001 to 2006 by asking surviving cohort members to provide specimens of blood and urine.� Per- and polyfluoroalkyl substances (PFAS) are man-made chemicals that have been used to make firefighting foams, non-stick cookware coating, and other commercial products since the 1950�s. Perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), and other PFAS were detectable in sera from >98% of the general U.S. population, and levels of several PFAS differed by race/ethnicity. In 2017, the International Agency for Research on Cancer (IARC) classified PFOA, the most well-studied PFAS, as a possible human carcinogen (Group 2B) based in part on limited epidemiologic evidence of associations with kidney cancer. Notably, in OEEB�s prospective investigation in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial, positive associations were observed with risk of renal cell carcinoma (RCC), the most common form of kidney cancer, for serum concentrations of PFOA, PFOS and perfluorohexane sulfonic acid (PFHxS) at levels comparable to those seen in the general population. There is an important need to replicate findings of pre-diagnostic serum PFAS concentrations and RCC risk in general population studies with greater racial/ethnic diversity than exists in PLCO.� OEEB plans to conduct a nested case-control study of serum PFAS levels and RCC risk within the Multiethnic Cohort (MEC). This investigation will utilize banked serum samples and accompanying covariate data available for selected participants in the MEC. The aliquoted serum samples from selected MEC participants in the MEC will be used to measure serum concentrations of eight PFAS, as well as markers of kidney function (creatinine and cystatin C).� 2.1�� �OBJECTIVE The primary objective is to select cases and controls and aliquot their serum samples as a part of a nested case-control study of serum PFAS levels and renal cell carcinoma (RCC) risk within the MEC. 3.0�� �SCOPE The Contractor shall provide all personnel, labor, facilities, materials, and equipment necessary to perform the required tasks described in section 4 below. The Contractor shall select 1,113 cases and controls, aliquot serum samples, and prepare an analytic file that includes covariate data for the selected participants in the MEC. All data shall be coded and shall not contain any personally identifiable information (PII). �All fees related to sample transfer/shipping and the required measurements of serum PFAS levels and kidney function biomarkers shall be included in this purchase order.� 4.0�� �PURCHASE ORDER REQUIREMENTS The Contractor shall perform the following tasks:� 1.�� �Prepare a Specimen Selection and Aliquoting Plan. 2.�� �Select 1,113 cases, controls, and quality control samples by coordinating with NCI personnel. 3.�� �Prepare two aliquots of serum samples for each of the selected participants (one 250�L aliquot for serum PFAS measurements and another 150�L aliquot for kidney function marker measurements). The Contractor shall pack the samples on dry ice for the transfer/shipping from the repository to the laboratories. 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.� 5.�� �Prepare an analytic dataset that includes covariate data for each of the selected cases and controls. � 6.�� �Provide the NCI Technical Point of Contact (TPOC) with copies of the Excel sample documentation files and the accompanying covariate dataset.� 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 facility.� 9.0�� �REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All written deliverables (e.g. specimen manifest and phenotype data) shall be sent electronically to the NCI Technical Point of Contact (POC) in a Microsoft compatible format, such as Microsoft Excel or text file. The NCI TPOC shall review and respond regarding approval or revisions of each of the files within 30 calendar days of receipt. All deliverables shall be per the following deliverable schedule: DELIVERABLE NO. �� �DELIVERABLE DESCRIPTION �� �FORMAT REQUIREMENTS�� �DUE DATE 1�� �Confirm sample specifications and coordinate with NCI personnel�� �Confirmation of specifications via e-mail to the NCI TPOC and teleconference for coordination�� �10 days after award 2�� �File for aliquoted serum samples�� �Microsoft Excel file submitted via e-mail to the NCI TPOC�� �30 days after award 3�� �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�� �UNIQUE QUALIFICATIONS� The University of Hawaii Cancer Center manages and stores the prospectively collected specimens and data from the Multiethnic Cohort (MEC). As such, they are the only institution that have access to and can select and aliquot the samples and prepare the accompanying covariate dataset that will be used in this nested case-control study of serum PFAS concentrations and RCC risk in the MEC. It is essential to have careful records and inventory of the specimens and data. Specimens and data collected prospectively in the MEC are used by a large number of investigators for research projects, including previous investigations conducted by the NCI.� 11.0�� �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 12:00 PM EST on August 23, 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: 75N91021Q00223 on all correspondence. �
- Web Link
-
SAM.gov Permalink
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- Record
- SN06099380-F 20210819/210817230114 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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