COVID-19 Related Guidance Immediately Implementing Without Public Comment by FDA

FDA to implement all COVID-19 related guidance immediately, without public comment. But will open for public comment after implementation and FDA said it will still solicit comment, review all comments received and revise the guidance documents as appropriate.

The FDA is announcing the process for making available FDA guidance documents related to the COVID-19 public health emergency. FDA believes that this process will allow the Agency to rapidly disseminate essential Agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders.

In light of the need to act quickly and efficiently to respond to the COVID-19 public health emergency, FDA anticipates that prior public participation will not be feasible or appropriate before FDA implements COVID-19-related guidance documents. FDA anticipates it will issue COVID-19-related guidance documents for immediate implementation without prior public comment.

FDA also said that “Rather than publishing a separate Notice of Availability (NOA) for each COVID-19 related guidance document, FDA intends to publish periodically a consolidated NOA. This periodic NOA will announce the availability of all the COVID-19 related guidance documents that issued during the relevant period. The consolidated NOA will provide instructions to the public on submitting comments on COVID-19 related guidance documents, including the docket number(s) associated with each guidance document, information on how to view the dockets, and instructions for persons interested in obtaining a copy of a COVID-19 related guidance document. In addition, the guidance document will provide information to the public on submitting comments on the guidance document, including the docket number(s) associated with the guidance document and instructions for persons interested in obtaining a copy of a COVID-19 related guidance document.”

FDA intends to establish one docket for each Center or Office that may issue COVID-19 related guidance. The docket numbers associated with each Center or Office that may issue COVID-19-related guidance documents are as follows:

  • Center for Drug Evaluation and Research (CDER) COVID-19, FDA-2020-D-1136
  • Center for Biologics Evaluation and Research (CBER) COVID-19, FDA-2020-D-1137
  • Center for Devices and Radiological Health (CDRH) COVID-19, FDA-2020-D-1138
  • Center for Food Safety and Applied Nutrition (CFSAN) COVID-19, FDA-2020-D-1139
  • Center for Veterinary Medicine (CVM) COVID-19, FDA-2020-D-1140
  • Center for Tobacco Products (CTP) COVID-19, FDA-2020-D-1141
  • Office of the Commissioner (OC) COVID-19, FDA-2020-D-1142
  • Office of Regulatory Affairs (ORA) COVID-19, FDA-2020-D-1143

For more detail please refer below link:

https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-06222.pdf