Sec. 508. Improving FDA guidance and communication
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/bill/117/s/3799/is/section-508A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall develop, and publish on the website of the Food and Drug Administration— a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents, within centers, across the Food and Drug Administration, and across other applicable agencies; and a plan for implementation of such best practices, including across other applicable agencies, which shall address— streamlining development and review of guidance documents within centers and across the Food and Drug Administration; streamlining processes for regulatory submissions to the Food and Drug Administration, including through the revision or issuance of guidance documents; and implementing innovative guidance development processes and practices and transitioning or updating guidance issued during the COVID–19 public health emergency, as appropriate.
The Secretary, acting through the Commissioner of Food and Drugs, shall develop and publish on the website of the Food and Drug Administration a report on the practices of the Food and Drug Administration to broadly communicate with external stakeholders, other than through guidance documents, which shall include— a review of the types and methods of public communication that the Food and Drug Administration uses to communicate and interact with medical product sponsors and other external stakeholders; the identification of best practices for the efficient development, issuance, and use of such communications; and a plan for implementation of best practices for communication with external stakeholders, which shall address— advancing the use of innovative forms of communication, including novel document types and formats, to provide increased regulatory clarity to product sponsors and other stakeholders, and advancing methods of communicating and interacting with medical product sponsors and other external stakeholders, including the use of tools such as product submission templates, webinars, and frequently asked questions communications; streamlining processes for regulatory submissions; and implementing innovative communication development processes and transitioning or updating communication practices used during the COVID–19 public health emergency, as appropriate.
In developing and publishing the report and implementation plan under this section, the Secretary shall consult with stakeholders, including researchers, academic organizations, pharmaceutical, biotechnology, and medical device developers, clinical research organizations, clinical laboratories, health care providers, patient groups, and other appropriate stakeholders. For purposes of carrying out this section, the Secretary may update an existing report or plan, and may combine the reports and implementation plans described in subsections
(a)and
(b)into one or more documents. The Secretary shall— not later than 1 year after the date of enactment of this Act, publish a draft of the reports and plans required under this section; and not later than 180 days after publication of the draft reports and plans under paragraph (1)— publish a final report and plan; and begin implementation of the best practices pursuant to such final plan.