SOLICITATION NOTICE
65 -- Dynabeads CD3/CD 28 CTS 10ml
- Notice Date
- 10/24/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- 19-000151
- Archive Date
- 11/18/2018
- Point of Contact
- Grace P. Wong-Darko, Phone: 3014961199
- E-Mail Address
-
wongdarkogp@nih.gov
(wongdarkogp@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial supplies prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-100, August 22, 2018. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 19-000151. The NAICS Code for this solicitation is 325413. This will be awarded as Firm-Fixed Price. Prospective Offerors are responsible for downloading the solicitation and any amendments. It is the Offeror's responsibility to monitor the Fedbizops website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The solicitation is being issued as a Request for Quote (RFQ). The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) has a need for quantity of 10 Dynabeads CD3/CD28 CTS to isolate, activate and expand of human T Cells using Dynabead CD3/CD28 with an option to increase quantity up to 32. A. BACKGROUND AND OVERVIEW: The National Institutes of Health (NIH) is the nation's foremost federally funded biomedical research institution. It is comprised of twenty-seven Institutes and Centers. The NIH Clinical Center (CC) is the onsite hospital for the NIH campus, providing full support for clinical studies in inpatient and outpatient settings. The NIH CC is an 870,000 square-foot facility with the capacity to serve 200 inpatient beds and 82 day-hospital stations. The Cell Processing Section (CPS), Department of Transfusion Medicine, NIH CC is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CPS operates a core facility (Charles S. Carter Cellular Therapy Laboratory) for the manufacture, storage, and distribution of cellular therapy products. CPS manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study. B. OBJECTIVES NIH, CC, DTM, Cell Processing Section has a need for reagents and supplies to isolate, activate and expand of human T Cells using Dynabead CD3/CD28. C. STATEMENT OF WORK (SOW) -- SCOPE OF WORK Independently and not as agent of the Government, the Contractor(s) shall furnish all the necessary supplies in accordance with the technical requirement. Scope 1.The contractor will supply sufficient reagents and disposables to process approximately 100 cellular therapy products per year. 2. Shelf Life-Minimum - shelf life of any unopened reagent shall be at least 6 months unless otherwise agreed to from date of delivery at the DTM Cell Processing Laboratory. Shelf life of disposables shall be at least 1 year from date of delivery at the DTM Cell Processing Laboratory 3.The reagents and disposables may include but not limited to those listed below: GMP Dynabeads CD3/CD28 CTS 10mL 4.The Contractor shall supply technical support for all reagents and supplies and their performance characteristics at no additional cost to the Government. Performance Requirements /Tasks Deliverables The Cell Processing Section shall request reagents and disposables by telephone, fax or e-mail on an as needed basis. Initial delivery scheduled within 30 days of award. These reagents and disposables will be shipped overnight delivery Monday through Thursday to: NIH/CC/DTM/Cell Processing Section 10 Center Drive. BLDG. 10/ RM. 3C720 Bethesda, MD 20892-1288 Attention: Thai Truong or Timmy Ton Shipments will use government carrier at the expense of the government unless otherwise arranged. The contractor shall bear the cost of replacement for reagents and disposables found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments. Evaluation Factors Technical Acceptability Standard: The Government will evaluate the Offerors' ability to provide products and/or services that comply with the technical requirements below. Price: Prices will be evaluated, but not scored, to ensure they are fair and reasonable. Past Performance: Please provide up to three (3) references. D. PERIOD OF PERFORMANCE: One (1) Year beginning on or around November 9th, 2018 with one additional option period of 12 months. E. PRICING Provide a fixed price quote in accordance with the Statement of Work identified. The Government intends to make an award(s) to that offeror whose proposal provides the best overall value to the Government. F. EVALUATION AND BASIS FOR AWARD: Award will be made to the offeror whose proposal offers the best value to the Government. The Technical Proposal will receive paramount consideration in the selection of the Offeror for award. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. The trade-off selection procedures will be used to make a best value award decision. The Government reserves the right to make the award to the Offeror whose proposal provides the best value to the Government. PROPOSAL SUBMISSION FORMAT: Criteria shall be complete. The total number of pages for the technical quote shall not exceed ten (10) pages. ***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition. SAM: Vendors must be registered in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov. You will need the company Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to Grace Wong-Darko, Contract Specialist via email no later than November 3, 2018 12:00 p.m. Eastern Standard Time. No Phone Calls Will Be Accepted. PROVISIONS and CLAUSES: The Full text of the Federal Acquisition Regulation (FAR) can be accessed on the internet at https://www.acquisition.gov/far/ The following provisions and clauses apply: FAR 52.212-1, Instructions to Offerors Commercial Items; FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-3 Offeror Representations and Certifications-Commercial Items; FAR 52.212-4, Contract Terms and Conditions Commercial Item; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders--Commercial Items; FAR 52.217-7, Option for Increased Quantity; FAR 52.217-9, Option to Extend the Term of the Contract; FAR 52.222-3, Convict Labor (JUNE 2003); FAR 52.222-19, Child Labor--Cooperation with Authorities and Remedies (JAN 2018); FAR 52.222-21, Prohibition of Segregated Facilities (APR 2015); FAR 52.222-26, Equal Opportunity (SEP 2016); FAR 52.222-36, Affirmative Action for Workers with Disabilities (JUL 2014); FAR 52.222-50, Combating Trafficking in Persons (Mar 2015); 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011); 52.225-13, Restrictions on Certain Foreign Purchases (June 2008); FAR 52.232-18 Availability of Funds (APR 2013); FAR 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (JUL 2013). Please submit all proposals via email to: Grace Wong-Darko #19-000151 Grace.Wong-Darko@nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/19-000151/listing.html)
- Place of Performance
- Address: NIH/CC/DTM/Cell Processing Section, 10 Center Drive. BLDG. 10/ RM. 3C720, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Record
- SN05133754-W 20181026/181024230750-96c3bd4b71a9f046281044ada87edf7c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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