Center for Biologics Evaluation and Research (CBER) DBPAP/ Amb a 1-Specific Aptamers
ID: 75F40124Q00548Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

PSC

SPECIAL STUDIES/ANALYSIS- CHEMICAL/BIOLOGICAL (B504)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Original Source

https://sam.gov/opp/f629c2ee7e9e49769976bf57c26ec2dc/view
Timeline
    Description

    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is seeking small businesses to develop Amb a 1-specific capture and biotin-labeled detection aptamers for use in Enzyme Linked Immunosorbent Assay (ELISA) applications. The objective of this procurement is to create reference standard aptamers that will facilitate the measurement of biological potencies in commercial ragweed pollen extracts, which are crucial for allergen standardization in the United States. This initiative underscores the importance of advancing biotechnology in allergen detection, particularly in relation to ragweed, a common allergen. Interested parties should submit their quotes in response to Request for Quotations (RFQ) No. 75F40124Q00548, with the contract anticipated to last from September 30, 2024, to September 29, 2025. For further inquiries, potential offerors can contact Nicholas Bisher at Nicholas.Bisher@fda.hhs.gov.

    Point(s) of Contact
    Nicholas Bisher
    Nicholas.Bisher@fda.hhs.gov
    Files
    Title
    Posted
    75F40124Q00548 9-19-2024.pdf
    The document is a Request for Quotations (RFQ) No. 75F40124Q00548 issued by the U.S. Food and Drug Administration (FDA) for the development of Amb a 1-specific aptamers for Enzyme Linked Immunosorbent Assay (ELISA) applications. The RFQ invites small businesses to submit quotes for a contract with a firm-fixed-price purchase order anticipated to last from September 30, 2024, to September 29, 2025. Key information includes the background of the project, necessitated by the need for standardization of ragweed allergen extracts based on Amb a 1 content, and the scope detailing a phased development of monoclonal aptamers. The document outlines the technical requirements, including screenings and reports at various development phases, and specifies the delivery of identified aptamer pairs. Administrative details cite strict compliance with federal regulations and state that all submissions should follow outlined protocol by a specified deadline, with communications directed to the Contracting Officer and Contract Specialist. This RFQ illustrates the FDA's focus on advancing biotechnology in allergen detection while emphasizing adherence to regulations that promote opportunities for small businesses in government contracting.
    Attachment A - Pricing Worksheet.xlsx
    The document outlines a Request for Proposal (RFP) pertaining to Task Order FDA-75F40124Q00548, structured as a firm fixed-price contract. The contract is intended to span from the date of award for a duration of twelve months and includes deliverables divided into three distinct phases. The financial figures for each phase are to be determined, with a total firm fixed price yet to be specified. This RFP emphasizes the need for structured financial assessment of each phase, promoting clarity and accountability in federal contracting. It underscores the government's prioritized approach for rendering services through structured phases, reflecting best practices in procurement processes. Ultimately, this document serves as a framework for soliciting proposals from potential contractors equipped to fulfill the outlined phases, ensuring alignment with federal standards and goals.
    Attachment B- RFQ Question Submittal Form.xlsx
    The document serves as the RFQ Question Submittal Form for Request for Quotations (RFQ) No. 75F40124Q00548, specifically concerning the procurement of Specific Aptamers related to the DBPAP/Amb a 1 project. It outlines the necessary submission format for inquiries regarding various attachments, including the Statement of Work and Labor Category Descriptions, which are pivotal for potential offerors. The form includes a section for referencing specific parts of the RFQ, allowing for organized communication of questions and ensuring that offerors can seek clarification on crucial elements related to performance expectations, qualifications, and overall requirements. This structured approach aids in maintaining clarity throughout the bidding process, reinforcing the governmental intent to foster transparency and competitiveness among suppliers. The comprehensive handling of queries is vital to the procurement process, ensuring that all stakeholders have the necessary information to participate effectively. The RFQ aims to contract specialized services aligned with compliance and operational standards while managing intricate procurement details efficiently.
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