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SAMDAILY.US - ISSUE OF JANUARY 06, 2023 SAM #7710
MODIFICATION

R -- FDA Adverse Events Reporting System (FAERS) Data Management Program (DMP) Support Services

Notice Date

1/4/2023 2:45:05 PM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

518210 — Data Processing, Hosting, and Related Services
 

Contracting Office

FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 

ZIP Code

20705
 

Solicitation Number

75F40123R00015
 

Response Due

1/20/2023 12:00:00 PM
 

Archive Date

09/30/2023
 

Point of Contact

Nicholas Bisher, Phone: (240) 402-2773, James G. Whitt, Phone: 2404027627
 

E-Mail Address

Nicholas.Bisher@fda.hhs.gov, james.whitt@fda.hhs.gov
(Nicholas.Bisher@fda.hhs.gov, james.whitt@fda.hhs.gov)
 

Small Business Set-Aside

8A 8(a) Set-Aside (FAR 19.8)
 

Description

The U.S. Food and Drug Administration (FDA) intends to award an Indefinite Delivery-Indefinite Quantity (IDIQ) type contract with a 5-year ordering period, for the contractor to process FDA Adverse Event Reporting System (FAERS) reports, submitted by the public, by entering and coding the reports in a timely manner. This process is critical to ensure that the data can be reviewed by the FDA safety evaluation team to identify safety issues and respond to public health incidents to meet its regulatory mission. As a result, the FAERS data management services are required to achieve the results as follows: (1) Collect, receive and process mandatory and voluntary safety reports to make it available to the FDA Safety Evaluation Teams; (2) Establish quality assurance and training programs for the data entry process and management of coding services to enhance the quality of data for the FDA review and analysis; (3) Ongoing review of case processing activities for process improvement and program efficiency. The contractor shall perform these functional DMP services as follows: Performing services within the FDA Standard Operating Procedures (SOP) requirements. Development and enhancement of SOPs. Program management services for the oversight of data management operations, contractor staff training, records management, courier services and regular metrics reports. Receiving data in a variety of physical and electronic formats. Scanning physical documents into electronic formats, reviewing electronic submissions, and making the required corrections. Entering, registering, and processing data into the FDA computer system. Performing data analysis on case processing metrics, tracking services, and stakeholder/user support. Sorting and routing this data to the correct work area or correct FDA Center that regulates the product described. Medical coding of reports using various taxonomies (e.g., MedDRA). Performing quality assurance and quality control on data. Participating in the testing and validation of new software systems used to support new and more efficient data entry systems.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/27368bba46b6429d95605378ef656660/view)
 

Place of Performance

Address: Silver Spring, MD 20993, USA

Zip Code: 20993

Country: USA
 

Record

SN06555635-F 20230106/230104230105 (samdaily.us)
 

Source

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

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