Presolicitation Notice: Request for Proposals (RFP) N01CN87006-18 "PREVENT Cancer Preclinical Drug Development Program: cGMP Production of Vaccines and Biologicals for Cancer Prevention"

Notice Number: NOT-CA-19-004

Key Dates
Release Date: October 23, 2018
RFP Release Date: On/about October 31, 2018
Proposal submission date: On/about December 17, 2018
Estimated award date: May 15, 2019

Related Announcements
NOT-CA-19-011

Issued by
National Cancer Institute (NCI)

Purpose

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

Description:

NCI expects to release a Request for Proposals (RFP) to support the PREVENT Cancer Preclinical Drug Development Program to acquire services for the Current Good Manufacturing Practice (cGMP) production of vaccines and biologicals.

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 development and introduction of cancer immunopreventive agents, such as vaccines, remain one of the highest priorities for the PREVENT Program. As the PREVENT project cportfolio 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 requires that vaccines and other biological agents are produced under cGMP conditions. Vaccines to manufacture 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 Statement of Work (SOW) available through the pre-solicitation notice posted on FedBizOpps (https://www.fbo.gov/spg/HHS/NIH/FCRF2/N01CN87006-18/listing.html):

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 for the cGMP Pool 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 the work described in the Draft SOW available through FedBizOpps (internet address below). 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).

Place of Performance:
The place of performance will be the Contractor’s work site.

Set Aside Status:
None.

The Request for Proposal (RFP) N01CN87006-18 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 Proposal (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 DOWLOADING THEIR OWN COPY OF THE SOLICITATION AND ANY AMENDMENTS THAT MAY BE ISSUED. FAILURE TO DO SO WILL BE AT THE ORGANIZATION'S OWN RISK. ALL INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO THE CONTRACTING OFFICER AND CONTRACT SPECIALIST LISTED AS THE POINT OF CONTACT BELOW.

This advertisement does not commit the Government to award a contract.

Inquiries

Please direct all inquiries to:

Carrie Mills, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-624-1274
Email: carrie.mills@nih.gov

and

Mandie White, MBA
National Cancer Institute (NCI)
Telephone: 301-624-8756
Email: whitems@mail.nih.gov