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SAMDAILY.US - ISSUE OF AUGUST 16, 2023 SAM #7932
SOLICITATION NOTICE

66 -- Sartorius Stedim North America Inc.�s biological consumables

Notice Date
8/14/2023 3:06:29 PM
 
Notice Type
Combined Synopsis/Solicitation
 
Contracting Office
NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
 
ZIP Code
20892
 
Solicitation Number
RFQ-NIAID-23-2180509
 
Response Due
8/24/2023 1:00:00 PM
 
Archive Date
09/08/2023
 
Point of Contact
Lu Chang, Phone: 2406273034
 
E-Mail Address
lu-chang.lu@nih.gov
(lu-chang.lu@nih.gov)
 
Description
This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 �Streamlined Procedures for Evaluation and solicitation for commercial Items,� as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested. The Solicitation number is RFQ-NIAID-23-2180509 and the solicitation is issued as a Request for Quotes (RFQ). This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04 dated 6/02/2023.� The North American Industry Classification System (NAICS) code for this procurement is 334516 � Analytical Laboratory Instrument Manufacturing.� The requirement is being competed as a Brand Name or Equal requirement (considered full and open competition), and without a small business set-aside. National Institute of Allergy & Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. NIAID�s Vaccine Research Center (VRC) has full bench-to-bedside capabilities that enable rapid clinical evaluation of VRC discoveries. The VRC�s Vaccine Production Program Laboratory (VPPL) (collectively �Program�) has process, formulation, and analytical development groups and oversees cGMP manufacturing at the VRC�s pilot plant. Since the VRC/Vaccine Production Program (VPP) group is responsible for developing a scale able GMP process the items requested need to be standardized with what will be utilized in the VRC�s pilot plant and applicable to a GMP process and analytical standards that are used to characterize and release therapeutic and vaccine candidates to treat diseases including Covid-19 (SARS2-CoV), HIV, Influenza, Malaria, and Ebola.� Understanding these attributes are required for moving forward with a candidate to GMP manufacturing and clinical trials. Program is requesting these Cell Line Development and Cell Culture Development supplies in support of the VPP�s therapeutic and vaccine candidates.� VPP requests receiving these supplies in 4 shipments. Program specifically requires these additional Sartorius Stedium types of consumables because these are the types that are currently being used for research. This acquisition has unique technical and compatibility requirements. The items ordered herein fall into two categories: 1) They are specific to an instrument that require the specific items listed in to be from this manufactured by the requested manufacturer and/or 2) these items have historical applications and have already proven to be effective with Program�s specific biological candidates that are currently under VPP�s Cell Culture and Cell Line Development SOPs. Furthermore, the instruments for which these supplies are being requested are currently in use at Program�s GMP Pilot plant and are currently validated in their process. Attempts to modify the items the VPP utilizes in the development of the next generation vaccine and or therapeutics would result in the pilot plant having to re-tool and then re validated existing materials at the pilot plant.� This would then cause significant (greater than 12 months) delays in the VRC�s program goals and would harm Program�s research. The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for the following Brand Name of items: See attached Bill of Materials (BOM) Delivery Date or Period of Performance: The order shall be split into four deliveries that shall occur on the following estimated dates: 9/25/2023, 12/24/2023, 3/27/2024, 6/21/2024. Place of Performance or Delivery Location: Gaithersburg, MD 20878. The government intends to award a �firm fixed price� purchase order to the responsible contractor as a result of this RFQ that will include the terms and conditions set forth herein.� The award will be based on the technical capability to meet the requirements and price.� NIAID will evaluate quotes to determine the best value to the government.� NIAID will evaluate price only for those quotes, which are rated as technically acceptable. In the event quotes are evaluated as technically equal, price will become a major consideration in selecting the successful Offeror. The following FAR provisions apply to this acquisition: FAR 52.212-1 Instructions to Offerors Commercial Items FAR 52.212-3 Offerors Representations and Certifications - Commercial Items FAR 52.204-7 System for Award Management (Offerors must complete annual representations and certifications on-line at http://www.sam.gov/ in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Please ensure 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements � Representation FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment 52.204�26 Covered Telecommunications Equipment or Services-Representation FAR 52.211-6 Brand Name or Equal As prescribed in 11.107(a), insert the following provision: Brand Name or Equal (Aug 1999) (a) If an item in this solicitation is identified as ""brand name or equal,"" the purchase description reflects the characteristics and level of quality that will satisfy the Government�s needs. The salient physical, functional, or performance characteristics that ""equal"" products must meet are specified in the solicitation. ����� (b) To be considered for award, offers of ""equal"" products, including ""equal"" products of the brand name manufacturer, must- ���������� (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; ���������� (2) Clearly identify the item by- �������������� (i) Brand name, if any; and �������������� (ii) Make or model number; ���������� (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and ���������� (4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications. ����� (c) The Contracting Officer will evaluate ""equal"" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. ��� ��(d) Unless the offeror clearly indicates in its offer that the product being offered is an ""equal"" product, the offeror shall provide the brand name product referenced in the solicitation. The following FAR contract clauses apply to this acquisition: FAR 52-212-4 Contract Terms and Conditions Commercial Items FAR 52-212.5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors FAR 52.204-13 System for Award Management Maintenance FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations 52.252-2 -- Clauses Incorporated by Reference. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:� http://farsite.hill.af.mil/vffara.htm. By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov). Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov/far/loadmainre.html & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax. Submission shall be received not later than 08/24/2023 @ 4:00 PM EST Offers may be emailed to Lu Chang at � by 4:00 pm eastern standard time August 24, 2023.� Offers shall include RFQ number in the subject line (RFQ-NIAID-23-2180509).� Late submission shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All responsible sources may submit an offer that will be considered by this Agency.� Any questions or concerns regarding this solicitation should be forwarded in writing via email to Lu Chang at lu-chang.lu@nih.gov.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/484d7f1b8c8d4dce91ae78e473b961a5/view)
 
Place of Performance
Address: Gaithersburg, MD 20878, USA
Zip Code: 20878
Country: USA
 
Record
SN06789676-F 20230816/230814230055 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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