Inactive

PRE-SOLICITATION / NOTICE OF INTENT Notice of Intent: NOI-NIAID-2134738 NAICS – 325414, Biological Product Mfg This is a Notice of Intent, not a request for proposal. The National Institute of Allergy... PRE-SOLICITATION / NOTICE OF INTENT Notice of Intent: NOI-NIAID-2134738 NAICS – 325414, Biological Product Mfg This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with RAN Biotechnologies Inc, located in Beverly, MA, for a specific biological and media supply that must retained for continuity of scientific research by the Vaccine Research Center. The biologicals required from RAN Biotechnologies Inc have been used previously in studies of the universal influenza vaccine development which is still in the developmental phases and being reported to and overseen by the FDA. The FDA's Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States. Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act. The FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved, in order to ensure continuing safety. The FDA requires quarterly testing submitted by the NIAID and an approved third party, ensuring consistency with our testing contractors. For consistency reasons the FDA requires all the testing performed using the exact same biological products. Specs and requirements: 100g of neat 008-FluoroSurfactant – loaded into a 100mL glass media bottle, catalog # 008-FluoroSurfactant-100G, QTY 1 EA Delivery 1 week, ARO The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply or service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-2134738 to Dana Monroe at dana.monroe@nih.gov, by 5:00pm PDT Tuesday, July 19, 2022. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.