By: Bridget C.E. Dooling & Laura E. Stanley | November 2, 2021
This Minnesota Law Review article evaluates two specific flexibilities granted during the COVID-19 pandemic that made it easier for patients to access buprenorphine and methadone. First, the Drug Enforcement Administration (DEA) allowed practitioners to prescribe buprenorphine using telemedicine without first conducting an in-person medical exam. Second, the Substance Abuse and Mental Health Services Administration (SAMHSA) made it easier for patients to have a take-home supply of methadone, reducing many patients’ need to make a daily trip to an opioid treatment program. The White House Office of National Drug Control Policy indicated that extending pandemic flexibilities for treating opioid use disorder is a priority for the Biden Administration, and this Essay provides a roadmap for the executive branch to do so.
While Congress could certainly make the changes permanent through legislation, this Essay provides an independent assessment of whether DEA and SAMHSA have the statutory authority to extend these flexibilities after the COVID-19 public health emergency ends by making changes to their regulations using the notice-and-comment rulemaking process under the Administrative Procedure Act (APA). The main finding is that DEA and SAMHSA have regulatory mechanisms available to extend the flexibilities described above. In addition, the U.S. HHS Secretary’s opioid-specific public health emergency declaration could offer a longer term, but still impermanent, legal pathway to extend these flexibilities beyond the current pandemic.
March 23, 2021 | By: Steven J. Balla, Bridget C.E. Dooling, & Daniel R. Pérez
This article examines legislative action—introductions, cosponsorship, and votes—on resolutions of disapproval by committees, political parties, and congressional majorities.
January 21, 2021 | By: Bridget C.E. Dooling
This article examines how Congress has used the GAO’s legal opinion function to expand the application of the Congressional Review Act.
January 13, 2021 | By: Bridget C.E. Dooling
Independent regulatory agencies are taking various steps to improve their regulatory analysis, but none have fully opted in to OIRA’s regulatory review, likely because they expect that OIRA review portends the end of their ability to make independent decisions. But what if it did not?
August 25, 2020 | By: Bridget C.E. Dooling
Known mostly for its role as an auditor, the GAO’s activities have expanded over time. As part of this expansion, the GAO became a referee in an increasingly important part of the administrative state: determining which actions are “rules” under the Congressional Review Act. The significance of these opinions, which are not binding as a matter of law, has grown as legislators use them strategically in regulatory politics.
June 19, 2020 | By: Bridget C.E. Dooling
This working paper is forthcoming in The Ohio State Law Journal, and it proposes a new way forward for OIRA to perform benefit-cost analysis of draft regulations from independent agencies: bespoke regulatory review. Dooling draws on her 10+ years at OIRA in three different administrations to explain how bilateral negotiations resulting in agreements between independent regulatory agencies and OIRA could realistically fit each agency’s unique features.
September 12, 2019 | By: Brian F. Mannix & Bridget C.E. Dooling
In this article we focus on the executive’s authority to write a cross-government “rule-on-rules” to govern regulatory analysis, including benefit-cost analysis and the courts’ authority to enforce such a rule.
May 28, 2019 | By: Bridget C.E. Dooling
Executive Order 12866 describes U.S. policy on regulatory planning and review. It directs agencies to identify the nature and significance of the problem they are trying to solve with regulation, to identify alternative solutions, to assess the quantifiable and non-quantifiable costs and benefits of each alternative, and then to choose the option that maximizes net benefits to society, taking into account distributional effects and other considerations. That policy, which has governed U.S. regulation for several decades, is managed by the Office of Information and Regulatory Affairs (OIRA). It is also subject to several exemptions. In April 2018, the U.S. Department of Treasury and the Office of Management and Budget signed a historic memorandum of agreement (MOA) narrowing one of those exemptions. The MOA expands the number of Internal Revenue Service (IRS) regulatory actions for which IRS must comply with EO 12866. This action moved tax rules out of the “presidential tax-policy blind spot” as described by Professor Clint Wallace. This working paper offers a close study of the MOA and reveals six striking features that not only affect tax regulation, but also offer intriguing possibilities for (1) scholarly understanding of OIRA as an institution and (1) the future of regulatory review of independent agencies, which is the largest remaining exemption from OIRA review.
July 2, 2021 | By: Bridget C.E. Dooling
This comment offers two specific suggestions in response to issues that OMB sought comment on: Area 2 (Barrier and Burden Reduction) and Area 5 (Stakeholder and Community Engagement).
June 24, 2019 | By: Bridget C.E. Dooling
Early detection of breast cancer can save lives, and mammography is one of the screening tools that has contributed to reductions in breast cancer mortality. The FDA has a unique role in mammography and should be commended for proposing to update its rules, however, the proposed rule’s breast density notification raises issues of state preemption; lessons that can be learned from testing, evaluation, and assessment of prior state action; and analysis of distributional and equity effects.
By: Bridget C.E. Dooling | October 26, 2021
Bridget Dooling's essay for the Yale Journal on Regulation on Andrew Rudalevige's book, By Executive Order: Bureaucratic Management and the Limits of Presidential Power.
By: Bridget C.E. Dooling | October 6, 2021
Bridget Dooling's essay for the Yaale Journal on Regulation on Michael Livermore and Richard Revesz's book, Reviving Rationality: Saving Cost-Benefit Analysis for the Sake of the Environment and Our Health.
July 28, 2021 | By: Bridget C.E. Dooling
To improve equity in government decisions, OMB should update what counts as “burden” to include the psychological and other costs that paperwork and other disclosure requirements can impose on individuals. Second, while formal public comment periods remain important, OMB should also encourage agencies to leverage the entire regulatory development timeline—especially at the beginning—to engage the public in different ways.
June 7, 2021 | By: Bryce N.Y. Chinault
“I value the role ACUS plays in administrative law and practice, and I’m delighted to partner with Dr. Potter on this new study. While government contracting has attracted considerable attention because of the important issues it raises, this study will be the first to examine the ways that agencies employ contractors in rulemaking."
June 4, 2021 | By: Bridget C.E. Dooling
When an agency fails to send a rule to Congress—as required by the Congressional Review Act—can private parties sue? The Act has a special provision that bars review by the courts. The Supreme Court is considering whether to take a case that would clarify the scope of this bar on judicial review.
March 05, 2021 | Featuring: Bridget C.E. Dooling
Two members of the OMB review team for the Biden transition discuss what being part of such a team entails and what it was like leading a change in administrations during a pandemic.
August 25, 2020 | By: Bridget C.E. Dooling
The Government Accountability Office has become referee in an increasingly important part of the administrative state: determining which actions are “rules” under the Congressional Review Act. The significance of these opinions, which are not binding as a matter of law, has grown as legislators use them strategically in regulatory politics.
August 19, 2020 | By: Bridget C.E. Dooling
A new project by ACUS features several GW scholars; Steven Balla, Emily Hammond, and Bridget Dooling, plus other prominent scholars of the rulemaking comment process.
August 12, 2020 | By: Bridget C.E. Dooling
It’s always hard for an agency to envision all of the potential consequences that a proposed rule might unleash. That’s part of why the public comment process is so critical: it gives the public an opportunity to shine a light on what an agency missed or omitted.
May 15, 2020 | By: Bridget C.E. Dooling -- Originally published by the Yale Journal on Regulation
The COVID-19 pandemic has resulted in fewer days in D.C. than usual for Congress. One consequence of this decision is that, due to a quirk in how it’s calculated, the Congressional Review Act window has likely expanded, placing more rules in jeopardy than expected.
May 12, 2020 | By: Bridget C.E. Dooling -- Originally published by the Brookings Institution
As federal agencies scramble to respond to COVID-19, there’s another initiative rolling forward that you probably haven’t heard of, one that was built by data wonks and will influence regulation in ways we’re just now beginning to understand. As part of a new legal requirement, agencies are writing learning agendas to organize the way they approach research, including regulatory research.
April 22, 2020 | By: Bridget C.E. Dooling
The General Services Administration is considering how to modernize the eRulemaking program. The second of two public meetings is coming up on April 30 from 2pm-4pm ET. It will be held entirely online and it’s got a great lineup that packs a lot into 2 hours. Registration is easy and free.
March 24, 2020 | By Bridget C.E. Dooling
Congressional oversight of the regulatory process tends to be criticized for its anemia, but there are signs that Congress does sometimes engage in subtle and complex oversight techniques. One under-studied example of this arises under a 1996 statute called the Congressional Review Act (CRA) and hinges on the work of the U.S. Government Accountability Office (GAO). Known more for its role as an auditor, GAO has created a role for itself as a referee in an increasingly important part of the administrative state.
September 16, 2019 | By: Bridget C.E. Dooling
Judicial review of agency benefit-cost analysis is on the rise. Although courts are paying more attention to these analyses, they lack a robust toolkit to assess them. A cross-government rule, written by OIRA, could help by giving courts a set of standards against which they can assess agency rules.
March 5, 2019 | By: Bridget C.E. Dooling
Dooling explains how the longest government shutdown in history exposed aspects of the rulemaking process that usually go unseen. She also signals that long shutdowns imperil deregulatory initiatives, which need Federal workers to implement them.
November 26, 2018 | By: Bridget C.E. Dooling
OIRA recently issued a progress report on EO 13771, the two-for-one initiative, with a present value estimate of $23.4 billion in savings due to actions taken in FY 2018. More than half of these savings came from the U.S. Department of Health & Human Services (HHS). This Regulatory Insight takes a deep dive into the HHS figures and finds significant Medicare paperwork savings, but that the other deregulatory initiatives fall short of providing the kind of regulatory relief that President Trump has promised.
October 02, 2018 | By: Bridget C.E. Dooling
Dooling moderated the "Looking Back on 25 Years" panel, and in this commentary she shares her key take-aways as well as her overall impressions of the event, informed by her tenure in OIRA.
August 1, 2018 | By: Bridget C.E. Dooling
With the first 18 months of the Trump Administration complete, we can check in on his regulatory activity to date. This new analysis shows that Trump's regulatory activity is 70% lower than it was at the same point in the Obama Administration; a striking result for an administration that has made regulatory reform a signature issue.
June 1, 2021 | By: Steven J. Balla, Bridget C.E. Dooling, et al.
The report closes with a set of recommendations for agencies to address the challenges and opportunities associated with new technologies that bear on the rulemaking process. These recommendations cover steps that agencies can take with respect to technology, coordination, and docket management.
April 22, 2021 | By: Bridget C.E. Dooling & Laura E. Stanley
SAMHSA made it easier for patients to receive take-home supplies of methadone and buprenorphine during the pandemic, and it has the legal authority to extend this COVID-19 flexibility.
April 02, 2021 | By: Steven J. Balla, Bridget C.E. Dooling, et al.
This draft report for the Administrative Conference of the United States examines the legal, practical, and technical issues associated with processing and responding to mass, fraudulent, and computer-generated comments.
February 23, 2021 | By: Bridget C.E. Dooling & Laura E. Stanley
This report concludes that DEA and SAMHSA have the legal authority to extend the flexibilities granted during the COVID-19 public health emergency without additional authorization from Congress.
January 26, 2021 | By: Bridget C.E. Dooling
The new administration grabbed headlines with early executive actions on climate, COVID-19 response, racial equity, immigration, and more. But three less heralded Inauguration Day actions are likely to be equally significant for the regulatory system as a whole.
Executive Order (EO) 13771, known as the “regulatory two-for-one” EO, imposed new constraints on executive branch regulatory agencies, directing them to: (1) to cut two existing rules for each new rule issued and (2) offset any costs imposed by new rules while operating under a regulatory cost cap. The Office of Information and Regulatory Affairs (OIRA), part of the Office of Management and Budget (OMB), is responsible for implementing this EO and reporting on its progress. OMB has issued Regulatory Reform Reports for fiscal year (FY) 2017 and FY 2018. The fiscal year for 2019 ended recently on September 30, 2019. While we await the latest report, this article explains OMB’s current accounting methodology, gleaned from OMB’s guidance and other public documents, and highlights challenges of reporting agency performance in implementing EO 13771. It also contains our recommendations to improve the accuracy and accountability of both OMB’s annual reporting and individual agency actions.
Our article proceeds as follows. Part I details the OIRA guidance to agencies on what “counts” as an EO 13771 regulatory or deregulatory action. Part II describes OIRA’s accounting methodology for estimating agency cost savings. Part III elaborates on analytical concerns that flow from the administration’s current approach for estimating “counts” and “cost savings” and offers several recommendations for improving the content of agency actions and OIRA’s annual reporting on EO 13771.
American Bar Association: AdLaw Section Book
2018 Edition (also available on SSRN)
Authors: Michael J. Cole, Bridget C.E. Dooling, & Susan E. Dudley
Authors: Michael J. Cole & Bridget C.E. Dooling
2020 Edition (forthcoming)
Authors: Bridget C.E. Dooling & Bethany Davis-Noll
Slate, Bot-Generated Comments on Government Proposals Could Be Useful Someday, by Bridget Dooling & Michael Livermore
The Hill, We need a bespoke approach to independent agency regulations, by Bridget Dooling
The Hill, A Long Shutdown Hinders Trump's Deregulatory Efforts, by Bridget C.E. Dooling
The Hill, Trump hit the regulatory brakes, but hasn’t found reverse gear, by Bridget C.E. Dooling
The Hill, Justice Kennedy’s parting swipe against judges deferring to administrative agencies, by Bridget C.E. Dooling