SOLICITATION NOTICE
65 -- Evaluation of Homocysteine, ADMA Kits and Analysis
- Notice Date
- 4/24/2015
- Notice Type
- Presolicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-CSB-(HG)-2015-118-DLM
- Archive Date
- 5/16/2015
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Heart, Lung, and Blood Institute (NHLBI) and the National Human Genome Research Institute (NHGRI), intends to negotiate and award a purchase order on a non-competitive sole source basis to Research and Diagnostics Systems, Inc. (R&D Systems), 614 McKinley PL NE, Minneapolis, MN 55413-2610 to procure the following: Procurement: 1. Evaluation of Homocysteine and ADMA (human) ELISA Kit (Catalog # 30-7828), 200 Samples; and 2. Analysis of 200 human serum samples. Period of Performance: Base Year: 12-Months Option 1: Additional Samples as Needed Option 2: Additional Samples as Needed Background: The National Institutes of Health (NIH) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The NHGRI/DIR Cardiovascular Disease Section (CDS), Genomics of Metabolic, Cardiovascular and Inflammatory Diseases study the genomic and social determinants of complex diseases, in particular, on diseases that are disproportionately distributed by ethnicity and geography (e.g., diabetes, hypertension, heart and kidney disease, scleroderma and podoconiosis). MCIDGB researchers analyze genomic data to document and interpret the non-random distribution of human genetic variation, as well as to understand human history and how it informs disease distribution and etiology. Through large genomic initiatives, such as the Human Heredity and Health in Africa-H3Africa-project, this branch facilitates inclusion of populations currently underrepresented in the genomic revolution. MCIDGB investigators seek to understand the relationships and interdependencies among clinical phenotypes, human behavior, biosurveillance, and molecular, genomic and social determinants; their effects on gene expression; as well as their contribution to health disparities in cardiovascular disease. MCIDGB investigators utilize a combination of non-invasive imaging, biomedical informatics, system biology and genomic epidemiology to investigate the pathobiology of cardiovascular diseases. In addition, they conduct research related to the effects of social determinants on cardiovascular disease morbidity and mortality and on gene expression among disproportionately affected subpopulations. Justification: The purpose of this procurement is to acquire reagents and assay kits for the objective to conduct peripheral blood analyte assays to identify perturbations in analyte levels between control's and resistant hypertensives. R&D Systems will continue to assay the analytes for the Minority Health Genomics and Translational Research Bio-repository Database (MH-GRID) Network infrastructure, which facilitated the collection of bio-specimens and related multi-dimensional data elements within a consortium of minority-serving clinics for comparative analysis. This initiative expands the diversity of ancestral groups in national genomic medicine datasets and promises to accelerate the translation of ‘personalized medicine' into minority communities. The MH-GRID project has completed its participant recruitment activities and now represents an existing dataset and bio-repository that is being transferred to NHGRI for ongoing secondary analyses. Contractor Requirements: 1. Sample shipments from NHGRI/MCIDGB will include a packing slip listing the entire contents of the shipment. NHGRI/MCIDGB is responsible for the safe and timely arrival of samples to the Contractor and that the above requested sample volume is included. If requested, the Contractor shall return to NHGRI/MCIDGB confirmation of the arrival and condition of the sample shipment. 2. The Contractor shall keep the samples in Ultra Low freezers at s - 60° C, under continuous electronic monitoring of temperature. 3. The Contractor shall ensure assays are running according to the Contractor's Standard Operating Procedure (SOP) guidelines : a. A standard curve and controls will be run in duplicate on each microplate. b. All samples will run according to the standard protocol, and assayed in duplicate, if sufficient sample volume is provided by NHGRI/MCIDGB. If insufficient sample volume is received, samples may be run as singlets. c. In any case where the duplicate values (replicates) of the samples that have results within the standard curve range present a percent coefficient of variation greater than 20% (%CV> 20%), the sample will be re-assayed once at BTS' expense, if the sample volume is sufficient. If the repeat assay result presents %CV s 20%, the repeat result will be the final reported result. If the repeat result also presents %CV > 20%, all valid replicates will be evaluated in order to determine a final reported result. d. In any case where both replicates of the sample result in a value below the lowest kit standard, the sample value will be reported as less than the value of the lowest standard. e. The Contractor shall notify NHGRI/MCIDGB of any sample(s) whose value exceeds the highest standard. f. Results will be summarized into a spreadsheet containing the Contractor's accession number, NHGRI/MCIDGB patient or sample number, analyte results, and comments. If NHGRI/MCIDGB requests additional customization of the results report, this may increase the turn-around time. Regulatory Authority: This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source, only one responsible source and no other supplies or services will satisfy agency requirements. Additional Information: Industry Classification (NAICS) Code is 325414, Biological Product (except Diagnostic) Manufacturing and the Small Business Size Standard is 500 Employees. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001). The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-81 (April 10, 2015). This requirement is under the SAT of $150,000.00. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by May 1, 2015 and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2015-118-DLM, may be submitted to the National, Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2015-118-DLM/listing.html)
- Place of Performance
- Address: NIH, 10 Center Drive, Building 10, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03710243-W 20150426/150424234827-933638f12f6de2d5fa1d1fdcf3f5638b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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