SPECIAL NOTICE
Q -- Evaluation of CRP levels in a nested case-control study of ovarian cancer.
- Notice Date
- 5/28/2021 10:09:57 AM
- Notice Type
- Special Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NIH NCI ROCKVILLE MD 20852 USA
- ZIP Code
- 20852
- Solicitation Number
- 75N91021Q00101
- Response Due
- 6/9/2021 9:00:00 AM
- Archive Date
- 06/24/2021
- 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), Metabolic Epidemiology Branch (MEB) intends to procure laboratory testing services on a sole source basis from Boston Children�s Hospital (The Children�s Hospital Corporation) �located at 300 Longwood Ave, Bader 783, Boston, MA 02115. 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.� The anticipated period of performance shall be 12 months from the date of award. The anticipated award shall be a firm fixed price purchase order for non-severable services. 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 (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB) is focused on high-quality, high-impact research that seeks to understand the etiology of a number of malignancies and the role of various lifestyle factors and unique exposures. The MEB is conducting a nested case-control analysis of ovarian cancer among female cohort participants in the Ovarian Cancer Cohort Consortium (OC3). The OC3, based in the National Cancer Institute (NCI) Cohort Consortium, is composed of large population-based cohorts and clinical trials that volunteered to contribute data. To evaluate hypotheses related to ovarian cancer etiology, Levels of high sensitivity C-Reactive Protein (hsCRP) and lipid factions need to be quantified in heparinized plasma samples from a nested case-control study in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. 2.1������� OBJECTIVE The primary objective of this procurement is to assay case and control samples from a nested case-control study in the PLCO Cancer Screening trail to determine levels of hsCRP, total cholesterol, triglycerides, and HDL cholesterol. The data will be added to that which has already been collected across four other cohorts. Across these cohorts hsCRP will be utilized to evaluate the risk association with ovarian cancer as well as an adjustment factor in analyses evaluating hormones and metabolomics to determine whether these latter associations are independent of established associations between hsCRP and ovarian cancer. 3.0������� SCOPE The Contractor shall provide all labor, material, and equipment necessary to measure hsCRP, total cholesterol, triglycerides, and HDL cholesterol in 130 microliter aliquots of 576 heparinized plasma samples from the PLCO Cancer Screening Trial. 3.1������� PURCHASE ORDER REQUIREMENTS The contractor shall perform the following tasks: Receive 576 heparinized plasma samples (130 microliter volume) *Note: NCI shall ship samples on dry ice from the BioProcessing & Trial Logistics Laboratory (BPTL) at NCI via standard shipping within 5 business days of award. Shipping fees shall not be included in this order. � � � �2. Upon receipt, immediately store samples within standard laboratory freezers until assays are completed. � � � �3. Assay each heparinized plasma sample and record the levels of the following: high sensitivity CRP, total cholesterol, triglycerides, and HDL cholesterol. � � � �4. Send the Technical Point of Contact (TPOC) an electronic file of all assay levels. � � � �5. Destroy any surplus plasma that exists. 4.0������� TYPE OF ORDER This is Firm Fixed-Price Purchase Order. 5.0������� 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. 6.0������� PERIOD OF PERFORMANCE The period of performance shall be for 12 months from the date of the award. 7.0������� PLACE OF PERFORMANCE All assays shall be performed at the Contractor�s facility. 8.0������� REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All written and electronic deliverable products shall be submitted to the Technical Point of Contact (TPOC), as specified below in the form of an encrypted email. The Technical Point of Contact is: TBD at Award. DELIVERABLE -�Deliverable 1 DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS -�Assay levels as Excel files. DUE DATE -�Within 1 month of completion of testing. 9.0� � �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 https://www.hhs.gov/web/section-508/making-files-accessible/create-accessible-pdfs/index.html.� Federal government-wide guidance regarding accessibility of documents can be found at�https://www.section508.gov/, 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. 10.0����� UNIQUE QUALIFICATIONS The NCI/DCEG requires the Contractor to assay case and control samples from a nested case-control study in the PLCO Cancer Screening trial to determine levels of hsCRP, total cholesterol, triglycerides, and HDL cholesterol. Boston Children�s Hospital has previously provided measurements of hsCRP levels and lipid fractions in nested case-control samples sets from the following OC3 studies: Nurses� Health Study, Nurses� Health Study II, European Investigation into Cancer, New England Ovarian Cancer Case-Control Study, and the Women�s Health Study. Once the Contractor provides the data required under this procurement, the NCI intends to compare the data against the previous data that the Contractor provided for the studies identified above. Thus, the NCI shall be able to pool ovarian cancer case-control sets across cohorts to conduct a well-powered study. It is critical that hsCRP and lipid fractions are measured in the same laboratory as the previously measured assays using the same laboratory methods and internal standards to ensure that measures are scientifically comparable across the included cohorts. Further, the sample volume available (130 microliters) for analysis is limited, and the Boston Children�s Hospital has previously demonstrated the capability to measure hsCRP in 130 microliters and the lipid fractions in the residual sample volume. Using a different laboratory for this acquisition would make it impossible to compare levels with the existing OC3 data, thereby compromising the ultimate objectives of the study. 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 June 9, 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: 75N91021Q00101 on all correspondence.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/1d30d0934879493b93ccbe645a498908/view)
- Record
- SN06016202-F 20210530/210528230110 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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