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November 26, 2018
The Office for Human Research Protections (OHRP) announced in the November 19, 2018 issue of the Federal Register the availability of a draft guidance document that relates to three burden-reducing provisions in the revised Common Rule that institutions may choose to implement during the delay period (July 19, 2018 through January 20, 2019) for general compliance with the revised Common Rule. The draft guidance document is titled: “Activities Deemed Not to Be Research: Public Health Surveillance, 2018 Requirements.”
Public comments on the draft guidance document can be submitted during the following 30-day period: 11/19/2018 to 12/19/2018.
For the: Federal Register Notice of Availability (NOA), draft guidance document; instructions on how to submit public comments; and instructions on how to access comments that have been submitted, go here https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/activities-deemed-not-to-be-research-public-health-surveillance-guidance/index.html.