G
The response close date of the notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(2); and, is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 325412 and the business size standard is $38.5 million.
The anticipated award shall be a firm fixed price, indefinite delivery/indefinite quantity (IDIQ) type contract. The period of performance of the resulting IDIQ award shall consist of a 3-year ordering period.
It has been determined there are no opportunities to acquire green products or services for this procurement.
Background:
The vaccines required under the proposed contract vehicle will ultimately be used in an NCI clinical trial, the ESCUDDO study. This study has multiple components, including a non-inferiority randomized clinical trial of one vs. two doses of nonavalent and GlaxoSmithKline (GSK) bivalent vaccines; a comparison of new Human Papillomavirus (HPV) persistent infections between one and two doses of the vaccines to a contemporaneous unvaccinated group, similar in age and region of residence to the vaccinated groups; and, an economic evaluation of each vaccine and dose regimen, in the context of Costa Rica.
Required Item(s) / Specifications:
-Vaccines shall be provided in vial form
-Vaccines shall have a minimum of 18-month shelf life post-delivery
-Vaccines shall be stored at 2-8°C (34-46°F)
-Vaccines shall not be frozen
-The Contractor shall maintain the temperature of vaccines during
shipment
Delivery:
The Contractor shall deliver all required items within 14 days of each delivery order placed against the anticipated IDIQ award. Items shall be shipped to the following address:
National Cancer Institute - Frederick
1050 Boyles Street, Bldg 1050
Frederick, MD 21702-1201
Payment:
Payment authorization requires submission and approval of invoices to the NCI Contracting Officer's Representative (COR) and NIH Office of Financial Management (OFM), in accordance with the payment provisions in the order.
The vaccines required under this proposed contract vehicle will ultimately be used in an NCI clinical trial, the ESCUDDO study. The study has multiple components, including a non-inferiority randomized clinical trial of one vs. two doses of nonavalent and GlaxoSmithKline (GSK) bivalent vaccines; a comparison of new Human Papillomavirus (HPV) persistent infections between one and two doses of the vaccines to a contemporaneous unvaccinated group, similar in age and region of residence to the vaccinated groups; and, an economic evaluation of each vaccine and dose regimen, in the context of Costa Rica. Gardasil-9 vaccines were previously purchased, via purchase order number HHSN261201800084P, through Merck Sharp & Dohme Corporation (Merck) for the same study. Merck received Food and Drug Administration (FDA) approval to manufacture and commercially sell Gardasil-9. As the sole manufacturer of Gardasil-9, Merck is the only known source capable of creating and providing substantial doses of the vaccine to the NCI on demand. Additionally, the NCI/DCEG/IIB's procurement of vaccines through Merck is essential to maintain consistency and be scientifically comparable with previous data. The public health implications of this work are enormous and any delay in the delivery of the required vaccines would consequently delay policy change, and impede implementation of HPV vaccine programs. Therefore, Merck is the only source capable to meet the NCI needs for this procurement.
This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 11:00 AM EST, on January 2, 2018. All responses and questions must be via email to Contract Specialist, Megan Kisamore, at [email protected]. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, Contractors must be registered and have valid certification through SAM.GOV, and have completed Representations and Certifications. Reference: N02CO82516-8 on all correspondence.