Series Description

The FDA Grand Rounds is webcast monthly to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Lecture Description
With funding from the American Rescue Plan Act, FDA scientists leveraged an existing laboratory network normally tasked for foodborne pathogen surveillance to start sequencing SARS-CoV-2 from regional wastewater treatment plants across the US. New laboratory and analysis methods, public database structures, and FDA dashboard summarizing data collected were developed for this project.

References

• FDA’s Wastewater Dashboard: https://www.fda.gov/food/whole-genome-sequencing-wgs-program/wastewater-surveillance-sars-cov-2-variants
• FDA published protocols for sequencing SARS-CoV-2 from wastewater samples: https://www.protocols.io/workspaces/genometrakr1/publications?categories=wastewater-surveillance
• Karthikeyan, S., Levy, J.I., De Hoff, P. et al. Wastewater sequencing reveals early cryptic SARS-CoV-2 variant transmission. Nature 609, 101–108 (2022). https://doi.org/10.1038/s41586-022-05049-6

Series Objectives

• Discuss the research conducted at the FDA
  
• Explain how FDA science impacts public health

Learning Objectives After completion of this activity, the participant will be able to:

• Discuss how the FDA funds laboratories across the US to sequence the genomes of foodborne pathogens in food, water, or other environmental samples.
• Discuss why the FDA stood up wastewater surveillance of SARS-CoV-2 variants and sub-lineages.
• Discuss how important timely public data release is for pathogen surveillance.

Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.

Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

• Timme, Ruth, PhD, Research Microbiologist, FDA-CFSAN - nothing to disclose

Planning Committee

• Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
• Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
• Wheelock, Leslie, RN, MS, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose

CE Consultation and Accreditation Team

• Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Information
Registration is complimentary, therefore refunds are not applicable.