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The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH has issued a Tender notice for the procurement of a CSS: Bioanalytical Assay Methods Development and Performance for the Evaluation of Safety and Efficacy of an AAV-Based Gene Therapy Candidate in Methyl Malonic Acidemia (MMA) disease in the USA. This Tender notice was published on 27 Mar 2025 and is scheduled to close on 07 Apr 2025, with an estimated Tender value of Refer Document. Interested bidders can access detailed Tender information, eligibility criteria, and complete bidding documents by referencing TOT Ref No. 116860553, while the tender notice number is 75N95025R00039 and Registering on the platform.
Procurement Summary
Country: USA
Summary: CSS: Bioanalytical Assay Methods Development and Performance for the Evaluation of Safety and Efficacy of an AAV-Based Gene Therapy Candidate in Methyl Malonic Acidemia (MMA) disease
Deadline: 07 Apr 2025
Posting Date: 27 Mar 2025
Other Information
Notice Type: Tender
TOT Ref.No.: 116860553
Document Ref. No.: 75N95025R00039
Competition: ICB
Financier: Self Financed
Purchaser Ownership: Public
Tender Value: Refer Document
Purchaser's Detail
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Login to see detailsTender Details
Description
STREAMLINED SOLICITATION FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES
NON-COMPETITIVE
COMBINED SYNOPSIS / SOLICITATION
Title: Bioanalytical Assay Methods Development and Performance for the Evaluation of Safety and Efficacy of an AAV-Based Gene Therapy Candidate in Methyl Malonic Acidemia (MMA) disease
(i) This is a combined synopsis/solicitation for commercial products and commercial services 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; proposals are being requested and a written solicitation will not be issued.
(ii) The solicitation number is 75N95025R00039 and the solicitation is issued as a request for proposal.
This acquisition is for a commercial product or commercial service 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 Products and Commercial Services; and FAR Part 12—Acquisition of Commercial Products and Commercial Services and is expected to exceed the simplified acquisition threshold.
THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND 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), through its Therapeutics for Rare and Neglected Diseases (TRND) program, intends to negotiate and award a contract without providing for full and open competition (including brand-name) to BioAgilytix Labs LLC 2300 Englert Drive, Durham, NC 27713 for development of qualified bioanalytical assay methods and testing of clinical samples collected before and after administration of the AAV gene therapy product.
This acqui...
Active Contract Opportunity
Notice ID : 75N95025R00039
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NATIONAL INSTITUTES OF HEALTH NIDA
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
Original Published Date: Mar 26, 2025 11:58 am EDT
Original Date Offers Due: Apr 07, 2025 04:00 pm EDT
Inactive Policy: 15 days after date offers due
Original Inactive Date: Apr 22, 2025
Initiative: None
Classification
Original Set Aside:
Product Service Code: Q301 - REFERENCE LABORATORY TESTING
NAICS Code: 541380 - Testing Laboratories and Services
Place of Performance:
Documents
D1-SOW_MMA-BioA-Statement-of-Work-9DEC2024_LC24120.docx
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