Inactive

NOI-NIAID-2088014 NAICS – 541380, Testing Laboratories This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institu... NOI-NIAID-2088014 NAICS – 541380, Testing Laboratories 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 GenScript USA Inc to procure protein antigen production services for the influenza vaccine antigens project. This requirement is needed by the Structural Informatics Unit within the Laboratory of Infectious Disease (LID) and requires custom protein production that will be used to study immune responses in the support of ongoing universal influenza vaccine research studies. The laboratory studies the design, structure and epitopes display of the virus epitopes displayed in vaccine nanoparticles by immunogenicity, biochemical and electron microscopic techniques. In order to test the immunization of mice with the designed vaccine nanoparticles, these protein antigens need to be first produced. This entails cDNA synthesis and then protein expression and purification. Thus, the project entails gene synthesis and production work that will provide cDNAs and purified antigens used to carry out research in universal influenza vaccine development. cDNAs and protein from GenScript USA 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 by a single entity. 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 of 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-2088014 to Dana Monroe at dana.monroe@nih.gov, by 5:00 pm eastern standard time Tuesday, September 21, 2021. 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.