FDA-Approved Radiopharmaceutical Supplies and Nuclear Medicine Cold Kitsview on SAM.gov

FDA-Approved Radiopharmaceutical Supplies and Nuclear Medicine Cold Kits Dwight David Eisenhower Army Medical Center (DDEAMC), Fort Eisenhower, GA DISCLAIMER This is a Pre-solicitation Notice (Synopsis of Proposed Contract Action) to identify potential sources possessing the capabilities described herein. This Pre-solicitation Notice is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offer will be considered in response to this Pre-solicitation Notice. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this NOTICE or any follow-up information request. All information received in response to this NOTICE that is marked "Proprietary" will be handled accordingly. Responses to the NOTICE will not be returned. At this time, questions concerning the composition and requirements for a future solicitation will not be entertained. NOTE: At this time, no solicitation exists. Therefore, please do not request a copy of a solicitation. NO PHONE CALLS WILL BE ACCEPTED. It is the responsibility of any potential Offeror to monitor the SAM.gov site for the release of any subsequent solicitation. 1. NOTICE TITLE FDA-Approved Radiopharmaceutical Supplies and Nuclear Medicine Compounding Cold Kits for Dwight David Eisenhower Army Medical Center (DDEAMC). 2. PLACE OF PERFORMANCE (LOCATION) Dwight David Eisenhower Army Medical Center (DDEAMC) 300 Hospital Road, Fort Eisenhower, Georgia 30905-5650 3. BACKGROUND The Nuclear Medicine Section at DDEAMC requires a continuous, and reliable supply of Federal Drug Administration (FDA) approved active radiopharmaceuticals "hot doses" and non-radioactive compounding "cold kits." Currently, these requirements are satisfied under separate contracts. The Government intends to combine the active/hot doses, and the cold kit supplies, into a single, consolidated firm-fixed-price commercial contract. 4. DESCRIPTION & CLASSIFICATION The Contractor shall provide all necessary compounding facilities, certified personnel, USP-compliant cleanrooms, quality control testing, transportation, DOT-compliant vehicles, shielding, and related delivery accessories to fulfill routine and emergency nuclear medicine orders. A copy of the Draft Performance Work Statement (PWS) detailing the complete itemized workload and consolidated performance standards is attached to this NOTICE. Industry is highly encouraged to review the PWS and provide feedback or capability questions as part of their response. NAICS Code: 325412 – Pharmaceutical Preparation Manufacturing Size Standard: 1,250 Employees (SBA Manufacturing Standard) Product Service Code (PSC): 6505 – Drugs and Biologicals 5. CRITICAL LOGISTICAL REQUIREMENTS (NON-NEGOTIABLE) Due to the physics of isotopic decay and the critical nature of patient-care delivery timeline…