Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JULY 29, 2020 SAM #6817
SOLICITATION NOTICE

D -- Computerized Labeling Assessment Tool (CLAT) Services

Notice Date

7/27/2020 7:51:56 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

518210 — Data Processing, Hosting, and Related Services
 

Contracting Office

FDA CENTER FOR DRUG EVALUATION AND RESEARCH Silver Spring MD 20993 USA
 

ZIP Code

20993
 

Solicitation Number

FDA-20-SOL-1223486
 

Response Due

8/3/2020 8:00:00 AM
 

Archive Date

10/30/2020
 

Point of Contact

Laurel Woest, Steven Gagnon
 

E-Mail Address

laurel.woest@fda.hhs.gov, steven.gagnon@fda.hs.gov
(laurel.woest@fda.hhs.gov, steven.gagnon@fda.hs.gov)
 

Small Business Set-Aside

SBA Total Small Business Set-Aside (FAR 19.5)
 

Description

The Food and Drug Administration (FDA) intends to award a single award IDIQ to a small business�as follows:� Objective: FDA requires a comprehensive solution to best accomplish FDA specific mission objectives to ensure the safe use of drug products by minimizing medication errors related to drug product labeling. These objectives include the following: � Automate drug product labeling reviews � Implement and promote operational and cost efficiencies Scope of the Requirement The Government requires drug product labeling review support services for prescription and nonprescription drug products, that includes: � Develop a Computerized Labeling Assessment Tool (CLAT) that meets FDA standards (e.g., security, usability, cloud infrastructure) and can be used to perform automated labeling review activities � Implement CLAT in FDA�s environment that meets FDA�s infrastructure and security standards � Access and organize submitted labeling files � Apply automated capabilities to perform labeling assessments � Report review findings (includes analytics and data visualization tools) � Workload and performance metrics � Use of open source software, artificial intelligence and other novel or emerging technologies to develop CLAT � Test, and validate CLAT � Evaluate new or additional labeling review activities for possible automation � Enhance or expand functionality and capabilities for automated labeling review assessments by additional FDA offices and the public � Quality assurance, quality control, and quality improvement � User experience and user interface design � Integrate CLAT with other internal or external data sources
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/3d6f47170583418d8206b13fee62e9c8/view)
 

Place of Performance

Address: Silver Spring, MD 20993, USA

Zip Code: 20993

Country: USA
 

Record

SN05734374-F 20200729/200727230133 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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