Pre-Sol_02_28_23_1.pdf
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- Attached to
- Regulatory Support for Cancer Prevention Agent Dev Federal contract opportunity
- Solicitation number
- 75N98023R00011
About this file
This pre-solicitation notice provides details for a regulatory support services contract opportunity with the Department of Health and Human Services National Cancer Institute. The incumbent contractor will be replaced through this competitive small business set-aside, which seeks proposals for collecting, preparing, submitting, and continually updating regulatory data required by the FDA and other bodies for cancer prevention agent development. Key tasks include regulatory correspondence tracking, safety activities, document management, and IT support. The contract type will be cost-plus-fixed-fee, with a 12-month base period and four 12-month options extending over five years. The NAICS code is 541690 and size standard is $16.5 million. The solicitation containing evaluation criteria and response date will be available in mid-March 2023 on SAM.gov. Proposals are due in August 2023. Questions may be directed to the points of contact provided.
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Text version
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.
Note: This synopsis follows a Small Business Sources Sought notice that was released on April
25, 2022, under 75N91022R00018.
TITLE: “Regulatory Support for Cancer Prevention Agent Development”
This is a re-competition of contract HHSN2612011000017C awarded to CCS Associates located at 2001 Gateway Place, 350W, San Jose, California, on September 30, 2018.
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.
The Department of Health and Human Services (HHS), National Cancer Institute (NCI), Office of Acquisitions (OA), on behalf of the Division of Cancer Prevention (DCP), intends to procure, through a competitive small business set-aside, the specialized, recurring, services for the
“Regulatory Support for Cancer Prevention Agent Development” (RSCPAD), effort. The resultant contract is anticipated to be a definitive, Cost-plus Fixed Fee (CPFF), contract with a
12-month base period and four 12-month option periods. These services will be procured on a competitive basis.
The primary mission of the DCP is to conduct and support preclinical and clinical research in cancer prevention through medical and scientific expertise. The primary focus of the RSCAPD effort is to provide qualified regulatory expertise and technical support for the collection, preparation, submission, and continual update of regulatory data.
This procurement will allow for the following tasks: (1) Regulatory correspondence and administrative tracking (2) Safety activities (3) Maintenance of collaborating research agreement records (4) Coordination and documentation of Regulatory meetings (5) Document Management
(6) Regulatory review, reporting, and advisory activities (7) Process and Quality Assurance (8) information technology support, to include Information Management System and (9) review of
Informed consent documents.
The applicable North American Industry Classification System (NAICS) code for this requirement is 541690 –
“Other Scientific and Technical Consulting Services”, and the small business size standard is
$16.5 Million. The Product Service Code (PSC) is R499 – “Support – Professional: Other. It is critical that the contractor possess knowledge about, requisite experience working in, regulatory compliance, and technical expertise for the collection, preparation, submission, and continual update of regulatory data.
The solicitation requirements and documents, which will include instructions for submission, evaluation criteria and the response date will be available on or about mid- March 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 issued in August 2023. This action will be competed and set aside for certified small businesses. The services will extend for five years, to include one 12-month base period and four 12-month option periods.
You must be registered 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/.
Any responsible and eligible sources meeting the standards as detailed above, may submit a proposal, which shall be considered by the NCI, DCP agency. Additional questions may be emailed to the Contract Specialist at Brittany.gibau@nih.gov or the Contracting Officer, sara.mclaurin@nih.gov.
No attachments or links have been added to this opportunity.
https://sam.gov/ https://www.sam.gov/portal/public/SAM/ mailto:Brittany.gibau@nih.gov mailto:sara.mclaurin@nih.gov
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