Archive for June, 2019
DigitalGov and 18F launch practical guide to the Paperwork Reduction Act
Jun 21st
From: FedScoop
Written by Tajha Chappellet-Lanier
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Enter the PRA Guide, a new website developed by the DigitalGov and 18F teams at the General Services Administration, with subject-matter expertise from the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget (OMB), the office that oversees PRA clearances.
“The PRA Guide is a plain language guide which answers the most common questions like, ‘What is the PRA for?’, ‘Do I need clearance?’ and ‘What’s the process?’,” an introduction to the new site reads. “It aims to give federal employees confidence working with the PRA — and through this, lower the barriers to working effectively with the public.”
From Cherry Blossoms To Climate: EPA As Peace Corps For Environment?
Jun 12th
From: Inside EPA’s Environment Next
Views on climate change can turn on a single incident; former White House regulatory review chief and deregulatory advocate Jim Tozzi says his position changed after the National Cherry Blossom festival. “The whole land over the blossoms was mud,” he says, because of climate change-induced Tidal Basin flooding damaging the ground around the blossoming trees. While some squelching mud underfoot might seem a minor annoyance, it got Tozzi thinking about the broader impacts of increasing temperatures….
Read Complete Article (Paywall)
What’s a Major Rule? White House OMB Seeks to Clarify
Jun 12th
From: EHS Daily Advisor
By William C. Schillaci
The Office of Information and Regulatory Affairs (OIRA), which is part of the White House’s Office of Management and Budget (OMB), recently issued a memo clarifying how it determines if a proposed federal rule is a major rule and the level of cooperation the OIRA expects from federal agencies to assist in that determination. The memo applies to all federal agencies and departments and is particularly relevant to the EPA, which leads all its sister agencies by a wide margin in both the value of benefits from major rules and the associated cost of compliance.
The Office of Information and Regulatory Affairs: Myths and Realities
Jun 10th
From: Harvard Law Review
OMB Memo Outlines All FDA Guidance’s Will Be Reviewed by the White House Prior to Publication
Jun 5th
From: Policy & Medicine
The Trump administration recently issued new guidelines that will expand White House and congressional oversight and review of federal agencies’ rule-making processes, including those for traditionally independent agencies. This will have an especially important impact on the work of the FDA.
Impact on FDA
Generally, FDA releases draft and final guidances to help industry understand the agency’s thinking on a subject. Regulatory Focus notes almost 100 draft guidance documents are intended to be released by just the Center for Drug Evaluation and Research alone. This causes some confusion as to whether the agency regulates based on the non-binding guidance documents.