Drug Utilization: Hospital Inpatient & Emergency Dept. Data (Recompete)
ID: 75F40125Q00101Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA CENTER FOR DRUG EVALUATION AND RESEARCHSilver Spring, MD, 20993, USA

NAICS

Other Scientific and Technical Consulting Services (541690)

PSC

SPECIAL STUDIES/ANALYSIS- REGULATORY (B528)

Original Source

https://sam.gov/opp/689322c03a914c6e97447489a5f638fe/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking proposals for a contract titled "Drug Utilization: Hospital Inpatient & Emergency Dept. Data (Recompete)." The primary objective of this procurement is to gain immediate and unlimited access to commercially available drug utilization data for both adult and pediatric populations in hospitals, which will support the FDA's regulatory activities related to drug safety and utilization assessments. This data is crucial for enhancing public health safety and informing regulatory decision-making regarding marketed drugs. Interested parties should note that the contract may cover up to $5 million over several years, with a response deadline of April 16, 2025. For further inquiries, potential offerors can contact Ryan Alexander at ryan.alexander@fda.hhs.gov.

    Point(s) of Contact
    Ryan Alexander
    ryan.alexander@fda.hhs.gov
    Files
    Title
    Posted
    Pricing WS for Solicitation.xlsx
    The document outlines a structured template for offerors participating in government Requests for Proposals (RFPs) and grants, focusing specifically on budgeting for labor and Other Direct Costs (ODC). It contains specific sections for detailing labor categories, associated costs spread across multiple years, and required documentation for compliance. Key areas include assumptions regarding the pricing structure, calculations for total labor and ODC costs, and detailed breakdowns for travel-related expenses. Offerors are instructed to strictly follow the format, avoid altering formula cells, and clearly specify labor categories linked to established BPA or GSA rates. The template emphasizes thorough planning and adherence to government regulations to ensure responsive and compliant proposals that adequately reflect anticipated costs and resource allocation. This document plays a vital role in guiding offerors through the budget submission process for public contracts, promoting transparency and fiscal responsibility in government spending.
    RFQ_75F40125Q00101.docx
    The FDA's Request for Quote (RFQ) 75F40125Q00101 seeks access to hospital inpatient and emergency department drug utilization data. The primary objective is to provide FDA personnel with immediate and unlimited real-time access to commercially available data covering drug use across adult and pediatric populations in hospitals. The data will support regulatory activities aimed at drug safety and utilization assessments. The contract emphasizes both the provision of comprehensive, de-identified datasets and the Contractor's responsibilities for quality control, data management, and adherence to HIPAA regulations. It also outlines various methodologies for risk management studies, feasibility studies, and customized analyses, while requiring the Contractor to ensure the data's accuracy and security during processing and handling. The scope includes detailed access to drug and diagnosis data, including specific patient demographics and hospital visit information. The Contractor must also implement training sessions and maintain ongoing communication with FDA personnel. Ultimately, the FDA requires this access to enhance public health safety and support regulatory decision-making regarding marketed drugs. The contract may cover up to $5 million over several years, with provisions for quality assurance, program management, and performance evaluation.
    Lifecycle
    Title
    Type
    Drug Utilization: Hospital Inpatient & Emergency Dept. Data (Recompete)
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