CDC Determination: IRB Approval is Not Required

Attachment 7_IRB Determination Letter FMS 2022.docx

[PHIC] Fellowship Management System

CDC Determination: IRB Approval is Not Required

OMB: 0920-0765

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Memorandum

Date: May 9, 2022

From: Marion W. Carter, PhD

Associate Director for Science

Division of Scientific Education and Professional Development

Center for Surveillance, Epidemiology and Laboratory Services

Office of Public Health Scientific Services



Subject: ICR OMB 0920-0765 Fellowship Management System

2022 Request for Revision

Research Determination

To: Jeffrey M. Zirger, PhD

Chief, Information Collection Review Office

Office of Scientific Integrity

Office of the Associate Director for Science

Office of the Director

Centers for Disease Control and Prevention



Based on the description and justification for the Fellowship Management System activities, and the definition of research defined by Federal Policy for the Protection of Human Subjects (45 CFR 46), the request to collect and use data related to managing fellowship programs is not considered human subjects research, and therefore does not require IRB review or approval. This determination is reinforced in the determination documented in STARS, under accession number CSELS-BMA-7/6/21-710af.


If questions exist regarding the nonresearch determination or need for IRB review, please contact me at 404-639-8035 or acq0@cdc.gov.




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