Inactive

The Centers for Disease Control and Prevention (CDC) seeks sources and industry input for an upcoming solicitation. All responses received in response to this notice will be used to develop a sound ac... The Centers for Disease Control and Prevention (CDC) seeks sources and industry input for an upcoming solicitation. All responses received in response to this notice will be used to develop a sound acquisition strategy for this upcoming requirement. A. Background CDC has a mission to protect America from health, safety, and security threats, both foreign and in the U.S. The mission of the National Center for Immunization and Respiratory Diseases (NCIRD), a component of CDC, is the prevention of disease, disability, and death through immunization and by control of respiratory and related diseases. Despite the introduction of two live oral rotavirus vaccines into the routine national immunization in many countries, rotavirus remains a major cause of severe diarrhea and a major killer among children, particularly in low-income countries. CDC scientists have developed a proprietary inactivated rotavirus vaccine (IRV) technology (new human strains and a novel method for rotavirus inactivation) and demonstrated the immunogenicity in small animals (mice, rats and guinea pigs) and protective efficacy in piglets of this IRV by intradermal (ID) administration using an innovative dissolving microneedle (MN) patch. CDC has previously entered into contracts to manufacture IRV bulk material and fabricate an IRV microneedle patch under Good Manufacturing Practice (GMP) conditions. CDC now has a requirement to assess preclinical toxicology and safety of this IRV MN patch in rats in accordance with regulatory requirements. Establishment of IRV preclinical safety will help advance this vaccine for testing in phase I trial in humans and further clinical development towards the licensure. The advance on a simplified and heat-stable vaccine delivery technology could revolutionize immunization programs and save more lives among children throughout the world. CDC is contemplating soliciting this requirement using Federal Acquisition Regulation (FAR) Part 13 procedures. B. Draft Statement of Work A draft statement of work is attached to this notice. CDC contemplates the start of this project on or about April 2022. C. Sources sought CDC is seeking industry’s input on the availability of qualified sources with the technical capability to fulfill this requirement. Prospective vendors are encouraged to identify themselves as interested parties and submit a copy of their capability statement. Additionally, please indicate if your company is a small business concern. The successful vendor must be Good Laboratory Practice (GLP)-compliant and qualified to conduct toxicology studies according to U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) guidelines. Further, the successful vendor must have experience and expertise in the testing of vaccines for use in humans and in the preparation of documentation related to animal toxicology and human clinical trials. See additional requirements in the attached draft statement of work. D. Submitting information to CDC Information in response to this notice must be submitted electronically to Joshua Houston, Contract Specialist, at pkf5@cdc.gov. Please reference “Microneedle Patch Sources Sought” in your e-mail. Information may be submitted in the body of an e-mail or in document(s) attached to an e-mail. For questions or feedback to the draft statement of work, respondents are encouraged to submit a copy of the draft statement of work with “red-lined” edits and comments using the Microsoft Word track changes tool. An editable Microsoft Word copy of the draft statement of work is attached to this notice. Submission of information to CDC in response to this notice is requested no later than January 31, 2022, at 4:30 p.m. Eastern Time (ET). Feedback received after this date and time may not be considered. No phone calls or meetings will be accepted in response to this notice. E. Disclaimer This notice does not constitute a solicitation or a promise of a solicitation in the future. This notice is being provided for planning purposes only and does not commit the Government to any contractual agreements. No entitlement or payment of direct or indirect costs or charges will arise as a result of submission of responses to this notice. CDC will not accept proposals in response to this notice. No awards will be made in response to this notice. Responses to this notice are voluntary and will not affect any contractor's ability to submit a proposal if or when a formal solicitation is released. Proprietary information shall not be submitted in response to this notice. The Government shall not be liable for or suffer any consequential damages for any improperly identified proprietary information.