Inactive

This Sources Sought Notice (SSN) is posted to conduct market research for capabilities from potential sources for transition, storage, inventory, retrieval, distribution, and disposal of government ow... This Sources Sought Notice (SSN) is posted to conduct market research for capabilities from potential sources for transition, storage, inventory, retrieval, distribution, and disposal of government owned biological defense and pharmaceutical-related material, stored under cGMP conditions and subject to International Traffic in Arms Regulations (ITAR). This is a SSN for planning purposes only, as defined in FAR 15.201(e). This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this SSN. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback. This information will support Joint Project Lead - Enabling Biotechnologies (JPL-EB), a component of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). As such, JPL-EB is seeking the following information on current industry capabilities for transition, storage, inventory, retrieval, distribution, and disposal of government owned biological and pharmaceutical-related BD material, such as vaccines and drugs that are subject to regulations administered by the US Food and Drug Administration (FDA), the United States Pharmacopeia (USP), ITAR, and other related federal agencies. Such pharmaceutical material may include, but is not limited to, vaccines, drugs, other biologics, laboratory samples (prokaryotic and eukaryotic cells, viruses, fractions of cells, inorganic and organic chemicals), or clinical samples: Specific Requirements 1. Transition: Transition from all material from incumbent facilities in accordance with current Good Manufacturing Practices (cGMP) standards. See attachment for estimated quantity and storage conditions. 2. Storage: Shall provide temperature controlled storage services for FDA-regulated products and other biological and pharmaceutical-related BD material specified in accordance with current Good Manufacturing Practices (cGMP) Title 21 CFR Parts 210 and 211 standards. The facility shall have a routine monitoring and preventive maintenance program for equipment and storage conditions to ensure the integrity of stored material. 3. Inventory: Conduct a 100% material inventory within 10 days after transition, and 30 days prior to the conclusion. Additionally, provide monthly updates of the status of the inventory, documenting any changes that have occurred during the month. 4. Distribution and Receipt: Direct shipment of biological material to sites for use and testing, and receipt of biological material from laboratories working with the Department of Defense. 5. Disposal: Comply with applicable federal, state, and local regulations for medical waste disposal. Provide documentation of disposal disposition to the Government within 5 business days of destruction confirmation, and maintain accurate records of product accountability suitable for submission to FDA, and shall update the inventory log. SUBMISSION INSTRUCTIONS: All written responses must be received within fifteen (15) days of issuance of this SSN. Submissions should: (1) Use Microsoft Word or Adobe Portable Document Format (PDF); (2) Be sent to the POC identified below by email only; (3) Be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this SSN; (4) Include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(s); and (5) Not exceed 10 single sided pages in total (not including cover page and cover letter). Material that is advertisement only in nature is not desired. Please address responses to this notice to the Government Contracting Officer, Richard Totten: richard.w.totten2.civ@army.mil. Please title the response with the announcement number, company name, and date. All questions must be submitted in writing via email. No telephone inquiries will be accepted.