SOLICITATION NOTICE
65 -- Reagents for Genetic Analysis (i.e. Sequencing) using the ABI313xL.
- Notice Date
- 1/31/2013
- Notice Type
- Presolicitation
- NAICS
- 325199
— All Other Basic Organic Chemical 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
- NHLBI-CSB-(HL)-2013-076-DDC
- Archive Date
- 2/21/2013
- Point of Contact
- Deborah - Coulter, Phone: (301) 435-0368
- E-Mail Address
-
dc143b@nih.gov
(dc143b@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This is a pre-solicitation / notice of intent synopsis for a sole source noncompetitive (including brand-name) award to Life Technologies for TF, BDT v3.1 RR-5000 & SEQ BUFFER. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of the Hematology Laboratory intends to negotiate and award a purchase on a sole source noncompetitive basis for TF, BDT v3.1 RR-5000 & SEQ BUFFER to Life Technologies, 850 Lincoln Centre Drive, Foster City CA 94404. BACKGROUND The Hematology Branch laboratory conducts research on the genetic basis of bone marrow failure diseases, viruses, acute leukemias, and hepatic cirrhosis. Some of the basic approach to these studies is the performance of genetic sequencing, for example, the multiple genes involved in telomere erosion and repair in blood samples of thousands of patients with acquired aplastic anemia and other syndromes per year or obtaining sequences of new viruses. The genetic analyzers have specific reagents/consumables associated with it. PROJECT DESCRIPTION The contractor shall supply all labor, materials, facilities, equipment, and supplies to perform or supply the following: Purpose and Objectives: The objective of this procurement is to provide reagents/consumables for genetic analysis. The HBL genetic analysis projects require reagents specific to the genetic analyzing machine. The TF, BDT v3.1 RR-5000 & SEQ BUFFER is the Big Dye Terminator (BDT) and the companion sequencing buffer which is specifically manufactured for use with our Applied Biosystems (ABI) Genetic Analyzer model 3130xL. The purpose of this procurement is to obtain the BDT which are reagents used in a reaction to decipher the sequence of Deoxyribonucleic Acid (or simply DNA). DNA sequencing is the process of determining the precise order of nucleotides within a DNA molecule. It includes any method or technology that is used to determine the order of the four bases-adenine, guanine, cytosine, and thymine-in a strand of DNA. Project Requirements: A. Contractor Requirements 1. Independently, and not as an agent of the Government, the contractor will delivered the reagents/consumables in accordance with the contract 2. Shipped the reagents/consumables in proper temperature conditions 3. The shipment of reagents/consumables must arrived at the times agreed upon 4. Contractor is responsible for ensuring the correct reagents/consumables and quantities are delivered Government Responsibilities: The government will receive the reagents/consumables and ensure they are error free; if a problem does exist the Government shall notify the contractor immediately that they intend to reject the reagents/consumables and arrange for a replacement of the shipment. Reporting Requirements and Deliverables: After receipt, inspection and acceptance of the reagents/consumables, the contractor is required to invoice the Government. The inspection will take place in the Hematology Branch Laboratory Building 10 Center Drive, Bethesda, Maryland 20892 JUSTIFICATION The sole-single justification for other than full and open competition is: • This reagent is specifically manufactured for use with the Government Applied Biosystems (ABI) Genetic Analyzer model 3130xL. To continue the DNA sequencing consistent and carry out the accurate research BDT must be used. Without this reagent it would render the instruments and prior research useless. • Investigators in the Hematology Branch study the clinical features and laboratory path physiology of a wide variety of bone marrow failure states, hematological malignancies, and single or multi-lineage cytopenias. There are many active IRB-approved Hematology Branch research protocols for these types of subjects where requests are made for CLIA regulated diagnostic genetic analysis. • An example of our protocols/projects requiring genetic analysis is for patients who participate in Clinical Protocol # 97-H-0041 or Project #94-H-0010. In these studies, some patients with aplastic anemia (AA) or severe aplastic anemia (SAA) are screened for Telomerase RNA component (TERC) gene mutations and these gene mutations are revealed by genetic analysis using the ABI 3130xL and BDT. TERC is an RNA gene found in eukaryotes, which is a component of telomerase used to extend telomeres. This procedure using BDT, the associated reagents and instruments/accessories manufactured by ABI is a diagnostic test regulated by The Centers for Medicare & Medicaid Services (CMS) who regulates all laboratories testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The Division of Laboratory Services, within the Survey and Certification Group, under the Office of Clinical Standards and Quality (OCSQ) has the responsibility for implementing the CLIA Program. Diagnostic under CLIA regulation cannot be modified without approval. • Based on the Sources Sought posted on 1/25/2013 under the following number HS-NIH-NHLBI-CSB-(SBSS)-2013-076-DDC, there were no small businesses that responded to this notice therefore, there are no small businesses capable of providing the requested product. REGULATORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) as set forth under FAR Part 13.106-1 (b) (1), Soliciting from a single source not exceeding the simplified acquisition threshold, and is exempt from the requirements of FAR Part 6, Competition Requirements. ADDITIONAL INFORMATION The North American Industry Classification Code (NAICS) is 325199 and the Size Standard is 1000 employees. This pre-solicitation / notice of intent is not a request for competitive proposals. This announcement constitutes the only notice; proposals are not being requested and a written solicitation will not be issued. The determination by the Government to award a purchase order on a sole source noncompetitive basis for TF, BDT v3.1 RR-5000 & SEQ BUFFER to Life Technologies, 850 Lincoln Centre Drive, Foster City, CA 94494 is based upon the responses to the sources sought synopsis published in the FedBizOpps on January 25th 2013, HHS-NIH-NHLBI-CSB-(SBSS)-2013-076-DDC, Title: Reagents for Genetic Analysis (i.e. Sequencing) using the ABI313xL. Any information received as a result of this pre-solicitation / notice of intent will be considered solely for the purpose of determining whether to conduct any future competitive procurements. Interested parties may identify their interest and capability for any future competitive procurement by responding to this notice in writing, no later than February 6, 2013 7:30am/EST. Responses to this notice shall contain sufficient documentation to establish the interested parties' bona-fide capabilities for fulfilling the requirement. All responses must reference this pre-solicitation / notice of Intent number NHLBI-CSB-(HL)-2013-076-DDC] and may be submitted electronically to the Contracting Officer: Deborah Coulter at coulterd@nhlbi.nih.gov or mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, 6701 Rockledge Drive, Suite 6142, Bethesda, MD 20892-7902, Attention: Deborah Coulter. Each response should include the following minimum Business Information: a. DUNS. b. Company Name. c. Company Address. d. Current GSA Schedules appropriate to this Award if applicable. e. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM). All offerors must register on the SAM located at https://www.sam.gov/portal/public/SAM/. f. Company Point of Contact, Phone and Email address
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(HL)-2013-076-DDC/listing.html)
- Place of Performance
- Address: NIH, Bethesd, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02977235-W 20130202/130131234916-bd4d32ebdbae75579bdaffe5a3bd7962 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |