# Safe Medication Use Canonical: https://abierto.us/opportunities/75f40125q00401 - Solicitation number: 75F40125Q00401 - Notice type: Combined synopsis and solicitation - Status: Closed. Deadline was September 18, 2025 at 11:00 AM EDT - Department: Department of Health and Human Services - Agency: Food and Drug Administration - Contracting office: FDA Center for Drug Evaluation and Research (75DKKN) - NAICS: 541990 All Other Professional, Scientific, and Technical Services - Product or service code: 7A21 Business Application off-the-shelf software delivered by perpetual license, which also encompasses enterprise level software enabling mission capability and business operational support. - Place of performance: Silver Spring, Maryland - County: Montgomery County (FIPS 24031). https://abierto.us/counties/montgomery-county-md-24031 - City: Silver Spring. https://abierto.us/cities/silver-spring-md-2472450 - First posted: September 9, 2025 - Last posted: September 16, 2025 - SAM.gov: https://sam.gov/workspace/contract/opp/471944747d4147d78a24dc340d66505e/view ## Description **Amendment 1:** The purpose of this amendment is to provide the answers to questions received. Background The Food and Drug Administration (FDA) / Center for Drug Evaluation and Research (CDER) is interested in obtaining products, services, and access to medication error[1] data collected from across the United States to inform regulatory and mission critical surveillance activities. FDA considers risks from medication errors in its overall assessment of drug safety. For example, regulatory actions to minimize medication error risks include requiring a boxed warning in the Prescribing Information to prevent dosing errors, changing a proprietary name to prevent wrong drug errors, and revising container labels to prevent wrong route of administration errors.[2],[3],[4] As the FDA continues assessing adverse events associated with the use of drug products in the postmarketing setting, FDA seeks to enhance data coverage through available products, services, and access to medication error data associated with FDA regulated drug products that is gathered nationwide from healthcare providers, consumers, patient safety organizations, published literature, and other sources of safety information. Objectives FDA’s objective is to acquire: Medication error case reports collected from across the U.S. population (including pediatrics and adults) throughout the medication use process[5] with sufficient granularity to understand the type of error, where the error originated, specific product(s) involved in the error, causes or contributing factors for the error, actions taken or recommended to prevent the error from occurring, adverse events and outcomes associated with the error. Unlimited, multi-user access to medication error data from an existing web-based analytics platform[6] that contains at least 5 years of medication error case reports from across the United States to support surveillance activities for identifying and tracking medication error safety related issues. Medication error data to inform appropriate responses to emerging public health safety concerns to ensure the safety of FDA-regulated drug products. Advanced subject matter expertise, training, and education to increase existing knowledge and experience within FDA on medication error prevention and analysis, including medication error risks, incidence trends, causes, and mitigation strategies. ## Publications - September 9, 2025: Combined synopsis and solicitation, due September 18, 2025 at 11:00 AM EDT. Notice 9b9d8dc6421a4ba9bc22c72d795c61f9. https://sam.gov/workspace/contract/opp/9b9d8dc6421a4ba9bc22c72d795c61f9/view - September 16, 2025: Combined synopsis and solicitation, due September 18, 2025 at 11:00 AM EDT. Notice 471944747d4147d78a24dc340d66505e. https://sam.gov/workspace/contract/opp/471944747d4147d78a24dc340d66505e/view ## Points of contact - Phillip Frame, Phillip.Frame@fda.hhs.gov, 240-402-7578 --- Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/75f40125q00401.