Inactive

0.9% Sodium Chloride for Injection, USP THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. THIS IS NOT A REQUEST FOR PROPOSAL (RFP). NO SOLICITATION IS AVAILABLE AT THIS TIME. Overview: The mission of the ... 0.9% Sodium Chloride for Injection, USP THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. THIS IS NOT A REQUEST FOR PROPOSAL (RFP). NO SOLICITATION IS AVAILABLE AT THIS TIME. Overview: The mission of the Joint Program Executive Office for Chemical Biological Radiological and Nuclear Defense (JPEO-CBRND) includes ensuring the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies and equipment necessary to counter the effects of biological, chemical, radiological agents, natural disasters or other emerging infectious diseases. When the Department of Defense and Other Government Agencies request federal assistance to support their response efforts, JPEO-CBRND ensures the right medicines and supplies get to those who need them most during a public health emergency or pandemic event. JPEO-CBRND is responsible for supplying ancillary medical products once the COVID-19 vaccines are available and can be paired with such a vaccine for deployment and administration. Scope of Effort: The purpose of this notice is to: Obtain information on the availability of commercially available 0.9% Sodium Chloride for Injection, USP in either a filled vial or pre-filled syringe at or near a 2ml fill volume which is manufactured in current Good Manufacturing Practices (cGMP) compliant facility. Obtain near-term manufacturing capability and capacity information to manufacture and distribute 0.9% Sodium Chloride for Injection, USP according to specifications In vials at a fill volume sufficient to withdraw 1.8ml of diluent material. In pre-filled syringes with a 1.8ml fill volume. Obtain information on the ability of the respondent to track, manage and distribute requested product to multiple locations throughout the country so that product arrives within 5 days of shipment request. For planning purposes, define earliest start date using 4 million units per month for five months using the most expedited means of transportation. Provide maximum capacity of capability per month. Make use of this information to inform COVID-19 response efforts. Submission Requirements: Respondents are asked to provide a cover page that contains the following information: All Point of Contact information (email addresses, phone numbers, and mailing address) DUNS number All relevant NAICS Codes Identification as a large or small business. If small, indicate the classification. Identification of services on any Federal Supply Schedules, if any, and the relevant schedule numbers. FDA registration information and related product 510K letters Provide company history of FDA approvals and inspections Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid JPEO, please segregate and clearly mark proprietary information. Please be advised that all submissions become the property of the Government and will not be returned. Response Guidelines: Interested parties are requested to respond to this RFI with a white paper. Submissions cannot exceed five pages (8.5” x 11”), single spaced, 12 point font with at least one inch margins. The response should not exceed 10MB for all items associated with the RFI response. The response must specifically describe the contractor’s capability to meet the requirements outlined in this RFI. Oral communications are not permissible. Beta.SAM.gov will be the sole repository for all information related to this RFI. Companies who wish to respond to this RFI should send responses via email to: MAJ Mountney at andrea.mountney.mil@mail.mil; not later than 28 August 2020 at 1300 EST.