SOLICITATION NOTICE
65 -- Purchase of 4,000 doses of the FDA approved HPV6/11/16/18/31/33/45/52/58 virus-like particles with Alum-adjuvant vaccine (Gardasil-9) from Merck
- Notice Date
- 11/22/2017
- Notice Type
- Presolicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- N02CP82510-57
- Point of Contact
- Reyes Rodriguez, Phone: 240-276-5442
- E-Mail Address
-
reyes.rodriguez@nih.gov
(reyes.rodriguez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Bethesda, MD 20892, UNITED STATES. DESCRIPTION The National Cancer Institute (NCI), DCEG, Infections and Immunoepidemiology Branch (IIB), plans to procure on a sole source basis 4,000 doses of the FDA approved HPV6/11/16/18/31/33/45/52/58 virus-like particles with Alum-adjuvant vaccine (Gardasil-9) from Merck Sharp & Dohme Corporation; One Merck Drive; Whitehouse Station, NJ, 08889-3400. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority permitting other than full and open competition is 41 U.S.C. 253(c)(1) as cited in FAR 6.302-2, "Unusual and Compelling Urgency", using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 325412 and the business size standard is 750 employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement. The National Cancer Institute will conduct a study with multiple components, including a non-inferiority randomized clinical trial of one vs. two-doses of Merck nonavalent and GSK bivalent vaccines, a comparison of new 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. The primary objective of this trial is to investigate the non-inferiority of one dose of the Merck nonavalent (Gardasil9) and the GSK bivalent (Cervarix) vaccines for preventing the endpoint of six-month or more persistent cervical HPV16 and 18-infections that were not present at baseline, compared to their respective two-dose regimens (delivered at 0 and 6 months) over four years of follow-up. In the secondary objective, IIB will evaluate other endpoints of interest, including other vaccine HPV types and all cancer-causing HPV types. Comparisons between the two vaccines will also be made (ancillary objectives). CONTRACTOR REQUIREMENTS Contractor must provide the following: 4000 doses of the FDA approved HPV6/11/16/18/31/33/45/52/58 virus-like particles with Alum-adjuvant vaccine (Gardasil-9) shall be provided, on demand. Vaccines shall be provided in 0.5ml vials. Vaccines should have a minimum of 18-month shelf life post-delivery. DELIVERY INSTRUCTIONS Contractor must deliver 4000 vaccines upon execution of this contract. During delivery, the temperature of the shipment shall be maintained. Vaccines shall be stored at 2-8°C (34-46°F). Do not freeze. These deliverables shall be shipped to the NIH address indicated below: Attn: TBD Frederick National Laboratory for Cancer Research Vaccine Clinical Materials Program 7116 Geoffrey Way Frederick, MD 21704 Email: TBD Phone: TBD The justification is based on urgent and compelling urgency. The FDA approved HPV6/11/16/18/31/33/45/52/58 virus-like particles with Alum-adjuvant vaccine (Gardasil-9) is the vaccine that is required for this study. Since Merck is the sole manufacturer of the Gardasil9 vaccine, they are only source known to create and provide 4,000 doses of the vaccine on demand. After some research in the US wholesale market, the NCI is not be able to find this number of doses of the vaccine on the market and in the required time frame from another vendor. Therefore, Merck is the only known source 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 1 PM EST, on November 27, 2017. All responses and questions must be in writing and emailed to Reyes Rodriguez, Contracting Officer via electronic mail at reyes.rodriguez@nih.gov. 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. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02CP82510-57 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/N02CP82510-57/listing.html)
- Place of Performance
- Address: See pre-sol delivery instructions, United States
- Record
- SN04747881-W 20171124/171122231203-e3bf4fb86a3f100f1241a4c5c58eb179 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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