In light of the Coronavirus Disease 2019 (COVID-19) public health emergency, this guidance is being implemented without prior public comment in accordance with 21 U.S.C. 701(h)(1)(C)(i)) and 21 CFR 10.115(g)(2), but it remains subject to comment in accordance with the Agency’s good guidance practices. Comments may be submitted at any time for Agency consideration.
Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic
comments to https://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register…