Regulatory and chemistry, manufacturing and control support for the production of phase 1 lots of inactivated rotavirus vaccine in dissolving microneedle patch

The Centers for Disease Control and Prevention intends to award a sole source labor-hour purchase order to LC Plus Consulting Inc for the procurement of regulatory and chemistry, manufacturing and control (CMC) support for the production of phase 1 lots of inactivated rotavirus vaccine in dissolving microneedle patch. LC Plus Consulting Inc is the only known vendor that has highly specialized expertise and experience in regulatory affairs of human rotavirus vaccines. Because this is a highly specialized service to provide regulatory support and consultation for manufacturing to deliver inactivated rotavirus vaccine using a microneedle patch, no other vendors or products that will meet our need. GMP Manufacturing and vaccine development are highly regulated by the FDA and require consultation with subject matter experts with specialized knowledge and experience. This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) (SAP) and 41 U.S.C. 3304(a)(1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive quotations; however, all quotations/responses received within five (5) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to the Contract Specialist at [email protected] by 5:00 PM Eastern Standard Time on Wednesday, April 15, 2019.