Presolicitation_Notice_N01CN87006-18.pdf

Pre-Solicitation Notice: RFP No. N01CN87006-18 PREVENT Cancer Preclinical Drug Development Program: cGMP Production of

Vaccines and Biologicals for Cancer Prevention

Contracting Office Address

Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, Riverside Five, Suite 400, 8490 Progress Drive, Suite 400, Frederick, MD 21701-4998.

Note: This synopsis follows the Small Business Sources Sought (SBSS) notices that were released on July 31, 2017 under HHS-NIH-NCI-SBSS-TSB-77019-18, HHS-NIH-NCI-SBSS- TSB-77006-79 and HHS-NIH-NCI-SBSS-TSB-77005-16, then followed by a Pre-solicitation notice and a Request for Proposal (RFP) N01CN77019-18, and subsequent Request for Information (RFI) NIH-NCI-RFI-TSB-87006-18. As discussed in the RFI, no proposals were received in response to the CGMP portion of the solicitation; therefore, the CGMP pool is being resolicited separately from the other two pools (Efficacy and Toxicology/Pharmacology). It is important to note that the $49,995,000 maximum IDIQ ceiling amount will continue to be shared among all IDIQ contracts issued in support of the PREVENT program, whether the awards result from RFP N01CN77019-18 or a subsequent RFP for the PREVENT CGMP services specified within this notice: N01CN87006-18.

Description

The NCI PREVENT Cancer Preclinical Drug Development Program (PREVENT;

http://prevention.cancer.gov/major-programs/prevent-cancer-preclinical) is a peer-reviewed research program managed by the Division of Cancer Prevention (DCP) with its primary mission to advance the preclinical development of cancer-preventive interventions and intermediate biomarkers toward clinical trials. The overall objective of the current acquisition is to provide a structured approach to drug and vaccine development, from discovery to the clinic. The development and introduction of cancer immunopreventive agents, such as vaccines, remain one of the highest priorities for the PREVENT Program. As the PREVENT project portfolio matures, multiple immunoprevention projects are expected to progress to the late stage of preclinical development, which will necessitate the supply of clinical-grade vaccines and other immunomodulatory agents in support of IND-enabling studies.

To meet the anticipated technical needs in the PREVENT pipeline, the NCI has a requirement for production of vaccines and other biological agents under cGMP conditions. Vaccines can be expected to span the spectrum of vaccine types, ranging from relatively simple peptide vaccines through protein vaccines, DNA or RNA vaccines, and vaccines packaged in viruses or a variety of organisms e.g. Listeria or constituted as virus-like particles. Other biologicals may include antibodies, ligands, cytokines, or growth factors affecting immune targets. Occasionally, preclinical grade products may be required for advanced development studies. Specifically, this acquisition for “cGMP Production of Vaccines and Biologicals for Cancer Prevention” (CGMP Pool) encompasses three main technical task areas: (1) analytical assay development and product characterization; (2) process development and related activities; and (3) CGMP manufacture, related activities and documentation, as described in detail in the attached Draft Statement of Work (SOW).

http://prevention.cancer.gov/major-programs/prevent-cancer-preclinical

The solicitation is anticipated to result in up to six (6) Indefinite Delivery/Indefinite Quantity (IDIQ) contracts for the cGMP Pool. There are no mandatory qualification criteria and there are no incumbent contractors for the cGMP pool. Each base IDIQ contract is anticipated to have a period of performance and ordering period of approximately 4.5 years. Awards are anticipated on or about May 15, 2019 to Offerors capable of performing all aspects of the work described in the Draft Statement of Work (SOW) attached to this notice. Task orders placed within the ordering period of the resultant base IDIQ contracts may extend up to five years beyond the end date of the base IDIQ contracts’ period of performance/ordering period. We anticipate task orders issued against the IDIQ contracts will be cost reimbursement and/or firm fixed price.

While the base IDIQ contracts will not have options, options may be included at the individual task order level.

This advertisement does not commit the United States Federal Government to award any contract.

The 2017 NAICS code for this acquisition is 541714 (formerly 541711) with a size standard of 1,000 employees. THIS ACQUISTION IS UNRESTRICTED (NOT A SET-ASIDE FOR SMALL

BUSINESSES).

The Request for Proposals (RFP) N01CN87006-18 solicitation is scheduled for electronic release on or about 10/31/18 and receipt of proposals will be due at 3:00 pm ET on or about 12/17/2018. The RFP will only be available electronically and must be accessed through the Office of Acquisitions, NCI homepage by using the following address: http://rcb.cancer.gov/rcb-internet/ or through FedBizOpps.gov https://www.fbo.gov/. All information required for submission of a proposal will be contained in the electronic Request for Proposals (RFP) package. No collect calls or facsimile transmissions will be accepted. It is the offerors’ responsibility to monitor the above-mentioned sites for release of the solicitation and any amendments. All responsible sources may submit a proposal, which shall be considered by the agency. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR

OWN COPY OF THE SOLICITIATION AND ANY AMENDMENTS THAT MAY BE ISSUED.

Failure to do so will be at your firm’s own risk. All inquiries shall be submitted electronically to the Contracting Officer and Contract Specialist listed as the points of contact herein.

Points of contact: Carrie Mills, Contract Specialist at carrie.mills@nih.gov and Christy Hunter, Contracting Officer at christy.hunter@nih.gov.

http://rcb.cancer.gov/rcb-internet/ http://rcb.cancer.gov/rcb-internet/ https://www.fbo.gov/ file:///C:/Users/millscl3/AppData/Local/Microsoft/Windows/Temporary%20Internet%20Files/Content.Outlook/LPDJXWK1/belangern@mail.nih.gov