Jan 3 -- The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Food and Drug Administration's Draft Report and Plan on Best Practices for Guidance.” This draft report responds to the Consolidated Appropriations Act of 2023, which directs FDA to issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents and a plan for implementation of such best practices. It also directs FDA to publish a draft report and plan no later than 1 year after enactment of the Consolidated Appropriations Act and to consult with stakeholders in developing the report and implementation plan. Submit either electronic or written comments on the draft report and plan by March 4, 2024.
Clear, concise, and timely communication through guidance documents is essential to the public health mission of FDA. FDA guidance documents are prepared for regulated industry, FDA staff, and the public to describe the Agency's interpretation of, or policy on, a regulatory issue. (§ 10.115(b) (21 CFR 10.115(b))). Unlike statutes and regulations, guidance documents generally do not establish legally enforceable rights or responsibilities (§ 10.115(d)), and are thus exempt from notice and comment requirements applicable to most rulemaking under the Administrative Procedure Act. (5 U.S.C. 553(b)(A); (d)(2)). However, the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA's Good Guidance Practices (GGP) regulation (§ 10.115) require FDA to provide an opportunity for public comment prior to implementation for all Level 1 guidance documents (i.e., 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), unless FDA determines that prior public participation is not feasible or appropriate. (21 U.S.C.371(h)(1)(C)(i); 10.115(g)). If FDA decides that public participation is not feasible or appropriate prior to implementation of a guidance document, FDA must provide for public comment upon publication and take such comment into consideration. (21 U.S.C. 371(h)(1)(C)(i); 10.115(g)(3)). For Level 2 guidance documents (i.e., guidance documents that set forth existing practices or minor changes in policy), the FD&C Act and FDA's GGP regulation require that FDA provide for public comment upon implementation. (21 U.S.C. 371(h)(1)(D); 10.115(g)(4)).
As part of FDA's Transparency Initiative, in 2011, FDA publicly released a comprehensive report entitled “Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency” (2011 GGP Report, available at
https://www.fda.gov/about-fda/transparency/transparency-initiative). The 2011 GGP Report identified “best practices” and made recommendations to streamline the development of guidance documents, reduce the time between issuing draft and final guidance documents, and improve access to guidance documents on FDA's website. Since 2011, FDA has continued to make significant strides to modernize and improve our best practices for the efficient prioritization, development, review, clearance, and issuance of our guidance documents.
The Coronavirus Disease 2019 (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. The facts and circumstances surrounding COVID–19 and the COVID–19 PHE enabled FDA to rapidly disseminate Agency recommendations and policies related to COVID–19 to industry and other interested parties, FDA staff, and the public, including patients and consumers. The Agency used Paperwork Reduction Act waivers, issuance of Level 1 guidance documents without prior public participation, and expedited external review of guidance documents, which translated into significant time savings. These tools were critical to the significant work FDA accomplished during the COVID–19 pandemic. Now that the PHE determined under section 319 of the Public Health Service Act is over, FDA is considering the lessons learned from that experience and reassessing our current best practices for guidance to look for additional areas for improvement consistent with our statutory and regulatory framework.
In accordance with section 2505(a) of the Consolidated Appropriations Act of 2023 (Pub. L. 117–328), FDA's “Draft Report and Plan on Best Practices for Guidance” identifies our current best practices for the efficient prioritization, development, issuance, and use of guidance documents. As a part of this draft report and plan, FDA is also considering opportunities to streamline processes for regulatory submissions through the revision and issuance of guidance documents and to implement innovative guidance development processes and practices. Pursuant to section 2505(c) of the Consolidated Appropriations Act, in this Federal Register notice announcing the availability of this document, FDA is seeking public comment on this “Draft Report and Plan on Best Practices for Guidance.”
FDA is soliciting comments on its “Draft Report and Plan on Best Practices for Guidance” from a broad range of commenters, including regulated industry; researchers; academic organizations; pharmaceutical, biotechnology, and medical device developers; clinical research organizations; clinical laboratories; healthcare providers; food manufacturers; and consumer and patient groups. We are particularly interested in feedback on the following areas: . . . .
Draft report and plan:
https://www.fda.gov/media/175121/download?attachment
FRN:
https://www.federalregister.gov/d/2023-28872