Notice & Comment

Notice & Comment

Notice & Comment

Supporting FDA Product Reviews with User Fees Alone

Cross Posted on Objective Intent. Budget documents released by the White House and FDA in May suggest the Administration intends to restructure medical product user fees, so that a greater percentage of the agency’s work is fully user fee funded.  The Secretary’s May 15 letter, explaining the President’s earlier Budget Blueprint, suggests the goal is […]

Notice & Comment

AALS Call for Papers: “New Voices in Legislation”

Here is the call-for-papers information for this terrific annual workshop at the AALS 2018 Annual Meeting: The AALS Section on Legislation & Law of the Political Process is pleased to announce that it will host a “New Voices in Legislation” program during the 2018 AALS Annual Meeting in San Diego, CA.  This works-in-progress program will […]

Notice & Comment

Event Announcement: “Reforming the Administrative State: Looking Back, and Looking Forward” (Hoover Institution)

On Friday, June 23, Stanford University’s Hoover Institution will host a public conference in Washington, DC, for discussion of new scholarship on regulation and administrative law. It is the latest event convened by the Hoover Institution’s “Regulation and the Rule of Law Initiative,” which was founded by Michael McConnell, Charles Calomiris, and the late Allan Meltzer, to […]

Notice & Comment

FDA User Fee Churn

(Cross posted from Objective Intent) This post is one of several this summer that will focus on the pending FDA user fee reauthorization legislation.  It starts with a basic introduction: what is “user fee reauthorization,” and why must it pass? The short version:  this summer we are talking about FDA’s medical product user fee legislation, […]

Notice & Comment

States’ Alliance To Follow Paris Accord Could Face Constitutional Obstacles, by Stephanie A. Maloney

The day after President Trump announced the United States’ withdrawal from the Paris climate agreement, the governors of New York, California, and Washington voiced their dissent by forming the “United States Climate Alliance.” This coalition asks individual states to remain committed to the main tenets of the Paris accord, including reducing greenhouse gas emissions by […]

Notice & Comment

Three Reactions to the DOJ’s Brief in CREW v. Trump

On Friday, 6/9/17, the U.S. Department of Justice filed its brief in CREW v. Trump, in which the plaintiffs allege that the President has violated Constitution’s Foreign and Domestic Emoluments Clauses through his continued ownership in Trump Organization entities. I’m sure I’ll have more to say on the case as it progresses, but here are […]

Notice & Comment

On Settlement Finality and Distributed Ledger Technology, by Nancy Liao

In their opening remarks at the March 3, 2017 roundtable, Carolyn Wilkins of the Bank of Canada and Andrew Hauser of the Bank of England described the efforts undertaken by their organizations to understand the capabilities and limitations of distributed ledger technology. Both central banks examined the potential use of distributed ledger technology in large-value […]

Notice & Comment

ACUS and Proactive Disclosure under the Freedom of Information Act, by Dan Sheffner

While much scholarly and public attention is paid to the Freedom of Information Act’s (FOIA) request-driven model of disclosure, less well known is the statute’s requirement that agencies publicly disclose certain government records without waiting for a request from the public.  Federal agencies must “make available for public inspection in an electronic format” specific types […]

Notice & Comment

How Payments Law Can Help Drive Innovation, by Jessie Cheng

Distributed financial technologies (DFT) and protocols are gaining a foothold in important payment and settlement applications in global markets. The software developed by Ripple is one example of an enterprise solution for financial institutions that improves the efficiency of their cross-border payments. However, robust DFT must be paired with clear commercial rules that define and […]