Indefinite Delivery Contract 75F40123D00028

Award Date 9/19/23
Last Date to Order 9/19/28
Ultimate Awardee
Not listed
Federal Contract Vehicle
Pricing Type
Firm Fixed Price
Legislative Mandate
Employment Eligibility Verification
National Interest Action
None
Award Type
Single
Primary Consortia Member
Not listed
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  • 75F40123D00028
    Indefinite Delivery Contract
  • 2
    Federal Contract Awards

The Department of Health and Human Services Food and Drug Administration awarded a single award indefinite delivery contract to Core Human Factors, Inc. with a potential value of $10,000,000. The contract aims to procure comparative use human factors studies to assess the impact of differences between the user interfaces of generic drug-device combination products and their reference listed drugs.

A firm fixed price delivery order for $1,035,113 was issued against this contract. Core Human Factors, Inc. will conduct a comparative use human factors study in Silver Spring, Maryland over a two year period to assess whether certain user interface differences between pen-injector combination products affect user error rates among diabetic patients. The study seeks to evaluate whether such differences could impact safe and effective use of these combination products.

The contract and delivery order were awarded non-competitively using no set-aside and will further the FDA's mandate to ensure the usability and safety of combination products through applied human factors research. Insights from these studies can guide regulatory reviews and product improvements. The prime contractor will perform the work in Silver Spring, Maryland through September 2025.

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