6505--Imiquimod 5% Cream and Placebo Manufacturing
ID: 36C26225Q0058Type: Sources Sought
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OF262-NETWORK CONTRACT OFFICE 22 (36C262)Gilbert, AZ, 85297, USA

NAICS

Pharmaceutical Preparation Manufacturing (325412)

PSC

DRUGS AND BIOLOGICALS (6505)

Original Source

https://sam.gov/opp/1073e90e56864aa7b426d3f700f1f86a/view
Timeline
    Description

    The Department of Veterans Affairs (VA) is seeking qualified sources for the manufacturing and supply of Imiquimod 5% Cream and a placebo, as part of a clinical study focused on cancer prevention. This procurement aims to identify capable vendors, particularly Veteran-owned and small businesses, to fulfill the requirements outlined in the attached Request for Information (RFI) and Statement of Work (SOW). The selected contractor will be responsible for adhering to stringent Good Manufacturing Practices and ensuring compliance with federal regulations, including the Non-Manufacturer Rule and Buy American Act, while delivering between 30,000 and 165,000 units annually over a three-year contract period. Interested parties must submit their capabilities statements by November 1, 2024, and can direct inquiries to Contracting Officer Anthony Dela Cruz at anthony.delacruz@va.gov or by phone at 562-766-2284.

    Point(s) of Contact
    Anthony Dela CruzContracting Officer
    (562) 766-2284
    anthony.delacruz@va.gov
    Files
    Title
    Posted
    RFI 36C26225Q0058.docx
    The Department of Veterans Affairs (VA) is issuing a Sources Sought Notice to identify qualified sources capable of manufacturing and supplying Imiquimod 5% Cream and a placebo, in line with the North American Industry Classification System (NAICS) code 325412. The goal is to ascertain interest from both Veteran-owned and small businesses that can fulfill the requirement. If sufficient Veteran-owned businesses or small business concerns are identified, the contract may be set aside for them. Interested vendors must demonstrate their qualifications by submitting a capabilities statement and confirming compliance with various federal regulations, including the Non-Manufacturer Rule and Buy American Act. Responses should indicate company size, authorization from the Original Equipment Manufacturer (OEM), and any existing federal contracts. The notice emphasizes that no gray market items are acceptable, ensuring vendors are authorized distributors or manufacturers. This process is part of the government's procurement strategy to promote participation from qualified small and Veteran-owned enterprises, while also ensuring compliance with federal contracting rules. The deadline for responses is November 1, 2024, with any potential solicitation to be published later on government procurement platforms.
    SOW .docx
    The document outlines a Statement of Work (SOW) for the manufacturing and supply of Active Imiquimod 5% cream and a matching placebo for a cancer prevention clinical study led by the VA Cooperative Studies Program in Albuquerque, NM. The purpose is to study the impact of chemoprevention on basal cell carcinoma recurrence. It details a three-year contract with an Indefinite Delivery/Indefinite Quantity (IDIQ) structure, allowing for fluctuating order quantities between 30,000 and 165,000 units annually. Key requirements of the supply include compliance with Good Manufacturing Practices, sourcing from FDA-approved manufacturers, and ensuring therapeutic equivalency to the reference brand, Aldara. The document specifies packaging and labeling protocols, expiration dating of at least 12 months, and strict acceptance criteria upon delivery. Regular quality assurance measures, including certificates of analysis, are mandated to uphold patient safety standards. The performance monitoring section emphasizes the importance of documentation, with clear consequences for non-compliance. Overall, the SOW reflects the government's focus on maintaining compliance and quality in pharmaceutical supplies within a clinical research context while ensuring safety and efficacy.
    Lifecycle
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    6505--Imiquimod 5% Cream and Placebo Manufacturing
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