FDA considers issuing more final guidances without comment period

The US Food and Drug Administration (FDA) is seeking comment on whether it should issue more guidances as final for immediate implementation without first submitting the undergoing the documents to the formal notice and comment period. The agency said that doing so would enable it to keep pace with “rapid scientific developments” and use limited resources more efficiently.

This input was requested in a notice published in the Federal Register earlier this week as part of its Good Guidance Practices and was accompanied by a 27-page report outlining the agency’s experience and proposed actions. FDA said that the COVID–19 Public Health Emergency (PHE) “pushed us to consider innovative approaches to streamline guidance issuance and regulatory submissions to reach a broad audience in an expedited manner.”

FDA was directed under Section 2505 of the Consolidated Appropriations Act of 2023 to update its 2011 guide on best guidance practices and to reflect any changes that need to be incorporated into these best practices as the result of the COVID–19 public health emergency.

The notice said throughout the PHE, the agency used more Paperwork Reduction Act waivers and issued more Level 1 guidance documents without prior public participation. FDA said that use of these mechanisms “translated into significant time savings.”

Level 1 guidance documents are guidance documents that include initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues or highly controversial issues, while Level 2 guidance documents describe existing practices or minor changes in interpretation or policy.

Now that the PHE is over, FDA is considering some lessons learned and is “reassessing our current best practices for guidance development to look for areas of improvement.”

FDA said that one of the lessons learned is that “issuing more guidance documents either as Level 1 guidance documents for immediate implementation, as FDA did during the COVID–19 PHE, or as Level 2 guidance documents would allow FDA to allocate its limited resources more efficiently, which would help FDA keep pace with rapid scientific developments and better serve the public health.”

FDA is also seeking input on whether there are any additional circumstances, categories of guidance documents, or guidance topics may be considered as a Level 1 guidance document for immediate implementation without prior public comment.

The agency is also asking whether any additional categories or types of guidance documents should be issued as a Level 2 guidance document to streamline the guidance process.

FDA would also like comment on whether to use more novel guidance document formats, such as the use of templates to accompany a guidance document, or the use of Q&A formats or flowcharts.

The agency is also asking about the usefulness of device-specific or disease-specials guidances in streamlining regulatory submissions and whether there any additional categories should be included.

FDA would like feedback from academic organizations; pharmaceutical, biotechnology and medical device developers; clinical research organizations; clinical laboratories; healthcare providers; food manufacturers; and consumer and patient groups.

The deadline for responding is 4 March 2024.

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FDA considers issuing more final guidances without comment period

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