Inactive

The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to LC Plus Consulting, 1575 Lakeshore Road W Suite 1, Mississauga, ON L5JOB-1 to provide r... The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to LC Plus Consulting, 1575 Lakeshore Road W Suite 1, Mississauga, ON L5JOB-1 to provide regulatory and chemistry, manufacturing and control (CMC) support for the production of phase 1 and 2 of inactivated rotavirus vaccine. LC Plus Consulting Inc is the only vendor that has highly specialized expertise and experience in regulatory affairs of human rotavirus vaccines to support this novel rotavirus vaccine development. Because this is a highly specialized service providing regulatory support and consultation for manufacturing to deliver inactivated rotavirus vaccine using a microneedle patch, no other vendors or products will meet the need. Manufacturing and vaccine development under Good Manufacturing Practice (GMP) conditions are highly regulated 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 10 U.S.C. 2304(c)(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 contract specialist at dvv1@cdc.gov by COB Friday, August 4, 2023