National Cancer Institute, Center for Cancer Research, Sponsor and Regulatory Oversight Support   3

Pre-Solicitation Notice

Request for Proposals (RFP) 75N91020R00027

Title: Sponsor and Regulatory Oversight Support

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, 9609 Medical Center Drive, Rockville, MD 20850-9700.

Note: This synopsis follows a Sources Sought Notice that was released on October 24, 2019 under HHS-NIH-NCI-SBSS-PCPSB-00034-39.

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.

Set Aside Status:

This requirement is 100% set-aside for Small Business. Only qualified Small Businesses under the size classification relative to the North American Industry Classification System (NAICS) code 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) need apply. The small business size standard is 1000 employees. An organization that is not a Small Business under the applicable NAICS code will not be considered.

Background:

The evaluation of therapeutics, immune modulations, cell therapy, vaccines, devices, diagnostics and treatment strategies in clinical trials is an essential element of the efforts of the National Cancer Institute/Center for Cancer Research (NCI/CCR). Through an extensive expertise of cutting-edge trials conducted by CCR intramural scientists, CCR manufacturing facilities and through a network of collaborators, the CCR supports a broad range of clinical trials, including single-center and multi-center Phase 1-4 clinical trials in people of all ages and risk categories. The CCR supports wide range of clinical trials in cancer therapy, with many modalities, cancer types and disease statuses (e.g. initial disease, metastatic disease, progressive disease failed previous treatment, etc.).

Project Requirements:

The purpose of this requirement is to provide for clinical trials sponsor and regulatory management support services to the NCI, the CCR and CCR investigators. Services shall include compliance with U.S. and international regulations, regulatory support to ensure Food and Drug Administration (FDA) regulation adherence, safety monitoring, oversight and reporting, clinical site assessment and interim monitoring, site essential regulatory documentation, trial master file support, sponsor quality management support, medical writing, administrative support, and computerized activity tracking, monitoring and reporting systems. The contract will also support management of multi-center trials in which the CCR is the Sponsor, in non-CCR sites recruitment and management.

The scope of this requirement consists of the following areas:

• Area 1: Project Management
• Area 2: Design Input Documents and Standard Operating Procedures for the SROS Service Areas
• Area 3: Development and Maintenance of a Quality Management System and Electronic Quality Management System (eQMS)
• Area 4: Clinical Site Monitoring
• Area 5: Safety Monitoring
• Area 6: Regulatory Support
• Area 7: Support of Clinical Studies
• Area 8: Quality Assurance and Quality Control
• Area 9: Specialized Expertise

The NCI intends to award ONE cost plus fixed fee contract for a one-year base period of performance, plus nine one-year options, on or about July 1, 2021.

Place of Performance:

The place of performance will be the Contractor's work site.

Additional Information:

Request for Proposal Number 75N91020R00027 will be available on or about September 10, 2020, with a due date for receipt of proposals on or about November 10, 2020.

The RFP is only available electronically and must be accessed through Contract Opportunities at the https://beta.sam.gov/ website and the National Cancer Institute homepage at http://rcb.cancer.gov/rcb-internet/index.jsp. All information required for submission of a proposal must be contained in the electronic RFP package. It is the Offeror's responsibility to monitor the above websites for the release of this RFP and amendments, if any. All responsible sources may submit a proposal, which shall be considered by the agency. This notice does not commit the Government to award a contract.

Offerors are required to submit their proposals online at the NIH electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov/NCI/home/) ONLY. Proposals submitted in hard copy (paper) will not be accepted. Proposals submitted by email will not be accepted. Collect calls will not be accepted. Facsimile transmissions will not be accepted. This notice does not commit the Government to award a contract.

POTENTIAL OFFERORS ARE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND ANY POSSIBLE AMENDMENTS. ALL INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO THE POINTS OF CONTACTS LISTED HEREIN.

Point of Contact:

Paula Wilkison, Contract Specialist; 240-276-7386; paula.wilkison@nih.gov

Alternate Point of Contact:

Sara McLaurin, Contracting Officer; 240-276-5438; sara.mclaurin@nih.gov