Walden, Hatch request stringent OMB review of proposed drug rebate rule

From: The Ripon Advance

U.S. House Energy and Commerce Committee Chairman Greg Walden (R-OR) and U.S. Senate Finance Committee Chairman Orrin Hatch (R-UT) have requested that the Office of Management and Budget (OMB) intensely review the economic impact of a proposed drug rebate rule before approving and publishing the rule.

OMB currently is reviewing the proposed Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection rule, submitted jointly on July 18 by the U.S. Department of Health and Human Services (HHS) and the Office of the Inspector General (OIG). The proposed HHS/OIG rule would alter the use of rebates commonly used during negotiations between drug manufacturers and pharmacy benefit managers.


GAO Questions Figures on Burdens Agencies Impose

Editor’s Note: See also Comments to ACUS on the Paperwork Reduction Act here and GAO’s Report “PAPERWORK REDUCTION ACT: Agencies Could Better Leverage Review Processes and Public Outreach to Improve Burden Estimates, here

From: FEDWeek

GAO has questioned the accuracy of agency reports on the hour and cost burdens they impose on the public through their information collection requests, “in part because of lack of clear guidance from OMB.”

“Inconsistencies in estimating respondent time costs could lead to inconsistent implementation of new requirements under Executive Order 13771 that agencies offset the incremental costs of new regulations with reductions in regulatory burden, including paperwork burden, elsewhere,” it added.


Former Thomas clerks are a presence in Trump administration

From: Missouri Lawyers Weekly

Associated Press


Trump’s choice of Neomi Rao as administrator of the Office of Information and Regulatory Affairs is illustrative of how former Thomas clerks also are shaping administration policy. Rao was a well-regarded critic of Obama-era regulations who had founded the Center for the Study of the Administrative State at George Mason University in Virginia with backing from the Koch brothers.

In her White House post, Rao has overseen the move to eliminate hundreds of regulations, to the consternation of watchdog groups and the cheers of a wide range of industry groups.


OMB Seeks Comment on Proposal to Create a Government Effectiveness Advanced Research (GEAR) Center

From: Notice & Comment | A Blog from the Yale Journal on Regulation and the ABA Section of Administrative Law & Regulatory Practice

by Emily Bremer

The proposed GEAR Center is described as “a public-private partnership to improve mission delivery, citizen services, and stewardship of public resources.”  OMB is requesting comments by September 14, 2018 from the public, academics, experts, and industry.  The Request for Information (RFI) appears to have been only been posted online, with a shorter notice of its availability published in the Federal Register.  From that Federal Register notice, which is out for public inspection today:


Federal Data Strategy: Team


The Federal Data Strategy Development Team is comprised of a core group of cross-disciplinary data experts from across the Federal Government.

The Leveraging Data as a Strategic Asset Cross Agency Priority (CAP) Goal commits the Administration to developing a long-term comprehensive Federal Data Strategy. Senior officials from the Department of Commerce, the Small Business Administration, the Office of Management and Budget, and the Office of Science and Technology Policy co-lead the CAP Goal. Co-lead staff members serve as a project managers supporting and facilitating the development of the Federal Data Strategy with significant stakeholder input. Select Federal Data Fellowship Chairs and Fellows conduct research and analysis; facilitate stakeholders; and distill feedback for the Federal Data Strategy.


Ex-Labor Official Now Second-in-Charge at Regulatory Agency

From: Bloomberg Law

Cheryl Bolen

Paul Ray, who had been serving as counselor to Labor Secretary Alexander Acosta , is now the second-highest regulatory official within the Office of Management and Budget, an agency official told Bloomberg Government.

Ray is the new associate administrator at the Office of Information and Regulatory Affairs, the agency within OMB that reviews all significant federal regulations and enforces the administration’s regulatory policies. He started about a month ago, another official said.

Read Complete Article [paywall]


Trade associations call on Office of Management and Budget for cost-benefit analysis in federal departments

From: Daily Energy Insider

by Chris Galford

A collective 101 business trade associations signed onto a joint letter last week addressed to Neomi Rao, administrator of the Office Information and Regulatory Affairs within Management and Budget (OMB), to make a case for cost-benefit balancing in federal offices.

“We believe the time has come for EPA to reexamine its statutory interpretations, and unless prohibited by statute, implement its regulatory statutes through cost-benefit balancing,” the organizations wrote. “Agencies must prepare cost-benefit analyses to support their most significant regulations, and to the extent permitted by law, not regulate unless the benefits justify the costs and the selected regulatory option maximizes net benefits to society.”


OIRA Data Call for the Fall 2018 Regulatory Plan & Unified Agenda, and FY 2019 Regulatory Cost Allowances

Editor’s Note: The following is an excerpt from OIRA’s June 18, 2018 Memorandum to Regulatory Policy Officers and Executive Directors of Agencies. The complete document is available here. Read the history of regulatory budgeting here.

From: OIRA

Proposed Cost Allowance Submissions under EO 13771 for Fiscal Year 2019

Section 3(d) ofEO 13771 provides that the Director of OMB shall identify a regulatory cost allowance for each agency for FY 2019. The Order further provides that “[n ]o regulations exceeding the agency’s total incremental cost allowance will be permitted in that fiscal year, unless required by law or approved in writing by the Director.”


Neomi Rao, Office of Info. & Reg. Affairs Administrator: The Administrative State

From: American Enterprise Institute


White House Meets Stakeholders on Small Business Health Rule

From: Bloomberg News

By Madison Alder


Final review by OIRA can take anywhere from weeks to months, or lead to a rejection that gets sent back to the DOL’s Employee Benefits Security Administration. The administration has fast-tracked this rulemaking as part of an attempt to provide Americans with relief from the ACA.


Officials who meet with groups can’t share information about the final rule, but advocates say it’s important to have their voices heard in each step of the rule-making.

Read Complete Article

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