Oncology Center of Excellence (OCE) Drug Labelling Initiative

Closed Solicitation Posted

This opportunity was awarded. See the award notice from .

Solicitation number
FDA-RFP-1227793
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Silver Spring MD 20993 USA

Notice details come from SAM.gov. Updated .

About this opportunity

The Food and Drug Administration seeks proposals to establish operations and deploy an iterative labeling evidence evaluation process to support the Oncology Center of Excellence Drug Labeling Initiative. Offerors must provide all necessary facilities, materials, personnel and services to automate data collection, develop documentation, conduct communications and stakeholder engagement activities, and provide publication and presentation support. Proposals will be evaluated on the basis of technical approach, management approach, past performance and price. The closing date for proposals is July 29, 2020, with questions due by July 6.

There is no set-aside designated for this requirement. Performance will take place in Silver Spring, Maryland. The contract type will be time and materials over a one year base period and a one year option period. Offerors are required to propose fully burdened commercial labor rates by category. The solicitation seeks to analyze the labeling of up to six specific oncology drugs to gather user feedback, collect prescription data, and make recommendations to FDA for potential label updates.

Notice text

2 versions

Update #2 · Latest ·

Amendment 1 to FDA solicitation number: FDA-RFP-1227793

The purpose of this Amendment 1 to FDA-RFP-1227793 is to provide responses to vendor questions received before the questions submission deadline stated in the solicitation. This Amendment 1 also includes revisions to the solicitation which are highlighted in yellow in the solicitation document. Please also note the revised bid submission deadline. Please refer to the attached amendment and FDA responses document for specific information.

Update #1 ·

FDA solicitation number: FDA-RFP-1227793

This is a combined synopsis/solicitation for commercial services and program support for a requirement entitled, "Oncology Center of Excellence (OCE) Drug Labelling Initiative". Please refer to the attached Request for Proposal for specific information.

Files

File Type Posted
Sol Doc_1227793_Amendment 1.pdf PDF
FDA-RFP-1227793_A1_FDA Responses.pdf PDF
FDA-RFP-1227793_Attachment 1 - RFP Questions Template.docx DOCX document
Sol Doc_1227793.pdf PDF

Notice history

Notice Type Posted
Oncology Center of Excellence (OCE) Drug Labelling Initiative Award Award Notice
This notice Latest solicitation Solicitation

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Opportunity Agency Set-aside Responses due
FDA/CDRH Scientific Technical Capacity for Regulatory Review Silver Spring, Maryland 20993, United States · NAICS 541611 FDA Office of Acquisition and Grant Services No set-aside

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