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REQUEST FOR INFORMATION 1.0 RFI TITLE: STERILIZATION of government furnished 3d printed swabs 2.0 AGENCY: U.S. Army Medical Materiel Development Activity 3.0 OFFICE: Warfighter Expeditionary Medicine ... REQUEST FOR INFORMATION 1.0 RFI TITLE: STERILIZATION of government furnished 3d printed swabs 2.0 AGENCY: U.S. Army Medical Materiel Development Activity 3.0 OFFICE: Warfighter Expeditionary Medicine and Treatment Project Management Office 4.0 LOCATION: 1430 Veterans Drive, Ft. Detrick, MD 21702 5.0 SUBJECT: The Warfighter Expeditionary Medicine and Treatment (WEMT) Project Management Office (PMO) of the U.S. Army Medical Materiel Development Activity (USAMMDA) is conducting market research to identify potential sources able to meet requirements for Sterilization of Government Furnished 3D printed Swabs. This market research may also assist with the further development and/or refinement of the requirements. 6.0 DISCLAIMER: This is an RFI as defined in FAR 15.201(e). This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will ot be entertained. 7.0 DESCRIPTION The Warfighter Expeditionary Medicine and Treatment (WEMT) Project Management Office (PMO) of the U.S. Army Medical Materiel Development Activity (USAMMDA) has a requirement to sterilize Government Furnished 3D printed Polyamide-11 swabs. Due to the COVID-19 Public Health Emergency and the immense world-wide demand for test swabs to enable diagnostic testing, there are significant shortages of nasopharyngeal swabs. In response to these shortages, 3D printed swabs have been developed to supplement supplies. The US Government has the capability to 3D print non-sterile swabs, henceforth known as Government Furnished Materials (GFM). The Government requires partners to sterilize this GFM compliant with US Food and Drug Administration (FDA) requirements. The Government is contemplating award of one or more indefinite-delivery indefinite-quantity contracts to fulfill this requirement. The purpose of this RFI is to obtain industry feedback on the draft PWS and identify potential sources capable of: •Sterilization capacity and capabilities utilizing autoclave CDC recommendations, without adversely affecting the physical, chemical, or structural properties of the GFM. The government has extensive data on the GFM post autoclave sterilization, utilizing the CDC recommended cycles. - CDC recommended cycles: 132 °C / 270 °F for 4 minutes in a steam sterilizer. Note: Do not exceed 20 minutes for 132 °C / 270 °F •Conduct testing to validate sterilization of 3D-printed swabs in accordance with USP 71 and provide test reports. •As applicable, to be in compliance with the FDA regulations including registration (facility) as a contract sterilizer and list the devices your facility has registered. Contract sterilizers are responsible for conformance with the portions of the current Good Manufacturing Practice (cGMP) regulations that pertain to the services they provide. The applicable regulations are the Drug (21 CFR Part 100.550 and/or Device (21 CFR Part 820) cGMP. •It is estimated that swabs will be shipped in lots of ~1776/lot with an estimated total overall minimum quantity of ~565,000 swabs (~319 lots) and a maximum quantity of ~4,600,000 swabs (~2,591 lots). Each swab is packaged as one swab/pouch. These deliveries are estimated to take place over the course of a 1 year timeframe. 8.0 SUBMISSION INSTRUCTIONS: All capable and qualified sources are encouraged to respond to this request. White papers should adhere to the following formatting and outline instructions: 1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF. 2. Cover Page (1 page) A. Title B. Organization C. Responder’s technical and administrative points of contact (names, addresses, phone numbers and email addresses) D. Topic area(s) addressed 3. Completed Attachment 1: Company Information 4. Provide comments and feedback on Attachment 2: Draft Performance Work Statement – Sterilization of Government Furnished Nasopharyngeal Swabs 5. In no more than 5 pages, discuss the responder’s ability to meet the following: A. Sterilization capacity and capabilities utilizing autoclaves according to the CDC recommendations listed above for GFM 3D-printed swabs. i. Ability to receive non-sterile materials for sterilization ii. Ability and capacity for sterilizing received government furnished individually wrapped and labeled 3D-printed swabs via autoclaving as per applicable FDA Quality System Regulations (QSRs) iii. Synopsis of any relevant experience with the FDA regulations such as: a. Sterilization process validation b. The specific procedure(s) for the sterilization process selected and the methods for controlling and monitoring the process. c. The Device History Records (including process control and monitoring records, acceptance activity records, etc.), as appropriate d. If the sterilization process is software controlled, details on the software validation e. Details on personnel qualified and trained to implement the sterilization process. f. FDA submissions/ marketing authorizations (e.g. 510(k) or DeNovo or Pre-Market Approval), status of facility registration, product listings, and any recent inspections and results. iv. Estimated costs per individually wrapped, sterilized, labeled, and packaged swab. Each pouch size is approximately 3” x 8.5”. v. Any associated intellectual property rights or patent coverage vi. Ability to conduct studies in order to validate the GFM 3D-printed swabs have been sterilized in accordance with USP 71 standards B. Ability to package (100 pouches/box) and ship sterilized GFM 3D-printed swabs to government facilities after completing the sterilization process C. Provide information related to the company’s quality systems (e.g. ISO 13485 or FDA QSR) D. Provide information related to the company’s registration and listing with the FDA E. System Description i. Provide a description of the equipment that will be used to meet the performance objectives specified above F. Cost i. Provide the Rough Order of Magnitude (ROM) cost estimate of the proposal (if able to represent in $/swab) ii. Provide the ROM cost estimate for testing to validate the GFM 3D-printed swabs are sterile in accordance with USP 71 guidance. iii. Cost drivers (i.e. Overall swab quantity expected for sterilization, swab quantity per sterilization run, shipping sizes, shipping destination, etc.) G. Schedule i. Proposed timeline/schedule for meeting sterilization capacity ii. Proposed timeline/schedule for sterilization process (receipt to sterilization to shipment back to government facility) Please note that responses are due no later than 05 March 2021. The preferred method of submission is via email. The point of contact for this action is Mr. Peter Mitchell. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis. 9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Mr. Peter Mitchell at Peter.d.mitchell8.civ@mail.mil no later than the close of business 05 March 2021. Telephonic communication will not be considered as submission nor receive response.