SOLICITATION NOTICE
65 -- Acquisition of non-GMP-grade GS-441524 for the Treatment of COVID-19
- Notice Date
- 5/25/2021 5:36:52 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95021Q00197
- Response Due
- 5/27/2021 5:59:00 AM
- Archive Date
- 05/28/2021
- Point of Contact
- Kimberly Espinosa
- E-Mail Address
-
kimberly.espinosa@nih.gov
(kimberly.espinosa@nih.gov)
- Description
- THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Avisa Pharma Solutions, Inc. (dba Cambrex), 3501 Tricenter Blvd Ste C, Durham, NC� 27713-1868. To ensure consistency among material, the current requirement must be manufactured by the same vendor that is manufacturing the cGMP and non-GMP material under Contract No. 75N95021P00063. Therefore, this acquisition is restricted to Avisa Pharma Solutions, Inc. (dba Cambrex). (i)�������� This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. (ii)������� The solicitation number is 75N95021Q00197 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13 - Simplified Acquisition Procedures, FAR Subpart 13.5 � Simplified Procedures for Certain Commercial Items, and FAR Part 12 - Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. (iii)������ The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-05, effective March 10, 2021. (iv)������ The associated NAICS code is 325412 and the Small Business size standard is 1,250 employees. This requirement is non-competitive and no set-aside restrictions are applicable. DESCRIPTION (v)������� The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), with a mission to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. NCATS is evaluating GS-441524 as a potential treatment for SARS-CoV-2 infection. GS-441524 is the parent nucleoside of remdesivir and has similar efficacy to remdesivir in vitro. GS-441524 is a stable crystalline compound with good physical properties for formulation, and the 3-step synthesis of GS-441524 makes it suitable for large scale production. The purpose of this acquisition is to obtain 3Kg of non-GMP GS-441524. This requirement includes the following items: Line Item 1: Three (3) kg of non-GMP-grade GS-441524. This batch must be developed using the same manufacturing processes and criteria used for previous batches manufactured for this project under Contract No. 75N95021P00063, and accompanied by a Statement of Analysis (SOA). �(vi)����� The material shall be delivered within six (6) months after the date of award. �Delivery of the GS-441524 shall be made to the below city / state, FOB Destination. The exact address and point of contact will be included on the resultant award. ����������� Chicago, IL 60616 The GS-441524 shall be shipped in a manner that does not adversely affect its quality. The contractor shall ensure that the vendor transporting the GS-441524 knows and follows the appropriate transport and storage conditions. See the attached Request for Quotations (RFQ) and other attachments for complete requirement details, terms, and conditions.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/694f8583e42949448cf64f567e148f10/view)
- Record
- SN06012589-F 20210527/210525230104 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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