Regulatory Transactions

From: ACA International

From: Association of Corporate Counsel

Elise N. Paeffgen | Alston & Bird LLP

On March 19, 2015, EPA sent its proposed rule, “Management Standards for Hazardous Waste Pharmaceuticals,” to the White House Office of Management and Budget (OMB) for pre-publication review.  This review may take up to 90 days (barring a one-time 30-day extension).  Unless OMB returns the rule to EPA for reconsideration, we expect the proposed rule to be released this summer.  This rule will have major implications for the pharmaceutical reverse distribution industry and the management of non-dispensable pharmaceuticals at health care facilities.

From: The Hill

By Timothy Cama

The White House is conducting its final review of a controversial regulation meant to protect streams from mountaintop removal mining.

The regulation from the Interior Department’s Office of Surface Mining would change a 2008 rule issued by the Bush administration that a federal court struck down in February 2014.

The White House Office of Management and Budget (OMB) said it received the rule for review Tuesday but did not provide any details of the proposal. The OMB review is the final step before the proposal, which would also cover other forms of surface coal mining, can be made public.

From: PlanSponsor

By Rebecca Moore

The submission represents the start of the regulatory process.

The U.S. Equal Employment Opportunity Commission (EEOC) sent a Notice of Proposed Rulemaking (NPRM) with respect to wellness programs to the White House Office of Management and Budget (OMB) for clearance.

The proposed rule, which was approved by a bipartisan vote, would amend the regulations implementing the equal employment provisions of the Americans with Disabilities Act (ADA) to address the interaction between Title I of the ADA and financial incentives as part of wellness programs offered through group health plans.

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Editor’s Note: For information on an effort to obtain correction of data quality flaws in information collected by the FTC through a generic clearance, please see here and here. For OIRA’s May 28, 2010 Memorandum, “Paperwork Reduction Act – Generic Clearances,” see here.

From: Aeronautical Repair Station Association

On Mar. 12, ARSA submitted its continued objections to the FAA’s request for generic clearance of information collections contained in Airworthiness Directives.

From: JDSupra Business Advisor

Wrap-Up of Federal and State Chemical Regulatory Developments, March 2015

by Bergeson & Campbell, P.C.

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On March 7, 2014, EPA withdrew a proposed rule intended to clarify which metal mining releases must be reported under the Toxics Release Inventory (TRI) program under Section 313 of the Emergency Planning and Community Right-to-Know (EPCRA). The proposed rule had been under review at the White House Office of Management and Budget (OMB) for nearly three years….

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From: Agri-Pulse

By Philip Brasher

WASHINGTON, March 16, 2015 – The Obama administration is promising to rewrite its proposed Clean Water Act rule to ensure that farmers have clear guidance about what streams, ditches and ponds will be regulated.

Speaking to the National Farmers Union annual convention in Wichita, Kansas, EPA Administrator Gina McCarthy said the final rule is being prepared for White House review, and that the administration still intends to complete it this spring.

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From: Sidley Austin

On February 24, the Office of Management and Budget’s Office of Internal Regulatory Affairs (OIRA) accepted for review the Department of Health and Human Services’ (HHS) notice of proposed rulemaking (NPRM) governing the protection of human subjects in research, also known as the “Common Rule.” This NPRM, entitled the “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” follows the advanced notice of proposed rulemaking (ANPRM) issued by HHS in July 2011. Once OIRA’s review is complete, the draft NPRM will be returned to HHS for final modifications and release for public notice and comment.