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U.S. Department of Health and Human Services (HHS)- Ancillary Acquisition to Support Pandemic Influenza Preparedness

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  • U.S. Department of Health and Human Services (HHS)- Ancillary Acquisition to Support Pandemic Influenza Preparedness

    Ancillary Acquisition to Support Pandemic Influenza Preparedness

    Solicitation Number: 13-100-SOL-00015
    Agency: Department of Health and Human Services
    Office: Office of the Secretary
    Location: Acquisitions Management, Contracts, & Grants (AMCG)
    May 10, 2013
    1:54 pm
    Solicitation Number:
    13-100-SOL-00015 Notice Type:
    Presolicitation Synopsis:
    Added: May 10, 2013 1:54 pm

    THIS IS A FORMAL SYNOPSIS OF A PROPOSED CONTRACT ACTION NOTICE IN
    ACCORDANCE WITH FAR 5.2. THIS COMPETITIVE ACTION IS BEING PROCURED
    UNDER FULL AND OPEN COMPETITION.

    The Department of Health and Human Services (HHS) intends to issue a Request for Proposal (RFP) for the acquisition of ancillary materials (needles, syringes, and combination units, isopropyl alcohol prep pads) from medical/surgical device manufacturers to meet the vaccine administration needs of the American public during a pandemic influenza event. To ensure coverage, manufacturers are expected to acquire, maintain and rotate inventories of integrated needle and syringe units of various types for pandemic preparedness. The management of these materials will be coordinated and integrated by HHS/ASPR/BARDA to provide long-term solutions that address and satisfy the vaccine administration requirements during pandemic influenza events and account for recent technology advances in vaccine manufacturing where the ability to produce influenza vaccines may outstrip the capability of medical/surgical manufacturers to maintain pace with sufficient needle/syringe units.

    The requirements for this RFP are as follows:
    1. Manufacture and make available for purchase up to 512 million FDA approved integrated needle and syringe combination units.
    2. Manufacture and make available for purchase up to 50 million FDA approved
    Needle/Syringe combination unit, 5ml or 6ml syringe, 20Gx1.5" needle, safety engineered.
    3. Manufacture and make available for purchase up to 88 million FDA approved needles, safety engineered, of the following sizes: 23Gx1", 25Gx1", 25Gx5/8".
    4. Manufacture and make available for purchase up to 88 million FDA approved 3ml Syringes, luer lock, safety engineered.
    5. Manufacture and make available for purchase up to 600 million Isopropyl Alcohol Impregnated Prep Pads, sterile, individually sealed, small.
    Note: Manufacturers who do not manufacture this product do not need to respond to this CLIN.
    6. Manufacture and make available for purchase up to 300 million FDA approved integrated needle and syringe combination units (conventional)
    7. Provide a manufacturing/production schedule representative of the surge capacity that can be made available to the USG for pandemic planning purposes.
    8. Upon request, provide a delivery schedule of the products that will be made available to the USG for pandemic Influenza response.
    9. Store, rotate, replenish and manage USG purchased products as vendor management inventory.
    10. Package, handle, and ship USG purchased products from contractor owned/contractor operated distribution facilities to USG designated domestic receiving locations. Receiving locations and Points of Contact information will be provided in task orders. For planning purposes, the USG may elect to identify up to ten (10) receiving locations in the following continental geographic regions; three (3) in the Northeast, two (2) in the South Central Midwest, two (2) in the North Central Midwest, and three (3) in the west region. The contractor shall include all costs and expenses for transit, delivery and insurance of USG product.
    11. Exchange USG purchased products for similar products where market demands indicate a change in user preference for other drug device products.
    12. Dispose of expired, adulterated or damaged USG products as directed by the USG. The contractor shall dispose of product following any federal, state, local regulation for the appropriate waste category and provide documentation on the completed disposal activity.
    13. Reporting and Inventory Requirements.

    ...
    "Safety and security don't just happen, they are the result of collective consensus and public investment. We owe our children, the most vulnerable citizens in our society, a life free of violence and fear."
    -Nelson Mandela
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