Pre-Sol_-_final_1.pdf

THIS PRE-SOLICITATION NOTICE IS NOT AN AUTHORIZATION TO START

WORK

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, Bethesda, MD 20892-9705

Note: This Pre-solicitation notice follows a Small Business Sources Sought notice that was released on May 2, 2022, and November 2, 2022 under HHS-NIH-NCI-SBSS-PCPSB-0017-BMG.

THIS PRE-SOLICITATION SYNOPSIS IS NOT AN AUTHORIZATION TO START WORK

THIS IS NOT A REQUEST FOR PROPOSAL (RFP); NO QUOTES OR BIDS ARE BEING

SOLICITED BY THE GOVERNMENT, NOR WILL ANY BE ACCEPTED FOR REVIEW IN

RESPONSE TO THIS SYNOPSIS.

Pursuant to the Federal Acquisition Regulation (FAR) 5.204, “Pre-Solicitation Notice”, this is a notification to inform the public of the Government's intent to award a definitive, Cost-Plus Fixed Fee (CPFF) contract based on the requirements detailed below.

Title: Technical Information Research Resources for Cancer Prevention Agent Development

Description:

This is a re-competition of contract HHSN261201800030C awarded to CCS Associates located at 2001 Gateway Place, 350W, San Jose, California, on September 30, 2018. The purpose of the acquisition is to provide a variety of critical cancer prevention information management functions necessary to support the identification, development, and qualification of potential cancer preventive agents for Investigational New Drug (IND) applications to the Food and Drug Administration (FDA) for clinical trials. Support for cancer preventive agent development includes the gathering and organizing of information from the research, pharmaceutical, and medical literature; preclinical and clinical technical project reports;

scientific meetings; and private industry documents provided to the NCI under confidentiality agreements. Support also includes abstracting and maintaining databases of technical reports; abstracting application materials for the PREVENT Cancer Preclinical Drug Development Program (PREVENT);

preparing specific chemical and biological agents and general class documents and structure/function and genomic/proteomic informational and statistical analyses for DCP programs; drafting and finalizing minutes of the PREVENT meetings; and identifying and reporting potential opportunities in cancer preventive agent development research. For almost 20 years a single support contractor has provided essential support services for identification of new chemo preventive agents for the NCI, Division of Cancer Prevention.

Background:

The National Institutes of Health (NIH) National Cancer Institute (NCI), Division of Cancer Prevention (DCP) has over 40 active clinical trials, 15 trials in development and is the sponsor for approximately 35 INDs (Investigational New Drug Applications). The mission of DCP is to plan and direct cancer prevention research, including testing promising agents in human clinical trials as part of a drug development program. Such testing falls under the purview of regulatory agencies such as the FDA and requires certain documentation for the use of the investigational agent. The collection, preparation, submission and continual update of this documentation is the focus of this acquisition.

The current contract was awarded September 30, 2018 as a 100% Small Business set-aside and is currently being held by CCS Associates under Contract No. HHSN261201800030C.

Technical and Contractual Requirement:

The purpose of this acquisition is to provide a variety of information management functions necessary to support the identification, development, and qualification of potential cancer preventive agents for IND applications to the FDA for clinical trials.

1) Task Area 1: Cancer Preventive Agent Identification, Documentation, and Prioritization

2) Task Area 2: Cancer Preventive Agent Data and Report Analysis, Status and Documentation

(PRECLINICAL)

3) Task Area 3: Cancer Preventive Agent Data and Report Analysis, Status and Documentation

(CLINICAL)

4) Task Area 4: Information Management System

5) General Tasks in support of DCP related to the SOW requirements

This acquisition will be a total small business set-aside. The Government anticipates that one (1) contract will be awarded with a base period of one year and four one-year option periods. The Product Service Code is R499 and the NAICs Code is 541690; the size standard for this acquisition is 19 million Dollars.

It is anticipated that the solicitation requirements and documents, which will include instructions for submission, evaluation criteria and the response date will be available on or about late March or early April 2023. Neither telephonic, mailed nor faxed requests for hard copies of the anticipated solicitation will be accepted. The solicitation will ONLY be available online; to download the solicitation offerors must access SAM.GOV (https://sam.gov/).

The Government anticipates a definitive contract to be awarded in August 2023. This action will be competed and set aside for certified small businesses. The anticipated period of performance is five years, comprised of one 12-month base period and four 12-month option periods.

You must be a valid entity in System for Award Management (SAM) Database to receive a Government contract award. You may register for SAM at: https://www.sam.gov/portal/public/SAM/.

Contracting Office Address:

9609 Medical Center Drive Bethesda, Maryland 20852

Primary Point of Contact:

Brittany Gibau Contract Specialist brittany.gibau@nih.gov Phone: 240-276-6863

Secondary Point of Contact:

https://www.sam.gov/portal/public/SAM/ mailto:brittany.gibau@nih.gov

Sara McLaurin Contracting Officer mclaurinsm@mail.nih.gov Phone: 240-276-5488

No attachments or links have been added to this opportunity.

mailto:mclaurinsm@mail.nih.gov