Regulatory Transactions

From: Americans for Safe Access

PFC Review Board Member, Jim Tozzi’s Role in Stopping the DEA from Classifying Drug in Schedule 1 Status

Mike Liszewski

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In its sudden rush to ban kratom, the DEA also violated several fundamental statutes including the Data Quality Act, Executive Order 12866, and the Office of Management and Budget’s (OMB) Peer Review guidelines. So in an unprecedented act, with help from Jim Tozzi and his team, the DEA withdrew their notice to classify kratom as a Schedule 1 drug. This is something that has never been done before, and the first time in DEA history that an organization was able to stop an order to place a substance in Schedule 1.

From: Bloomberg/BNA | Life Sciences Law & Industry Report 

By Jeannie Baumann

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“It is the goal of this administration to come out with a final rule,” Jerry Menikoff, director of the Health and Human Services Office for Human Research Protections, said Nov. 14.

OHRP Deputy Director Julie Kaneshiro added, “We could certainly decide not to move forward with some of the things being proposed” in response to the public comments about the proposed new Common Rule . The final rule also could have different effective dates for different provisions, Menikoff said. Both Kaneshiro and Menikoff were part of a “Dialogue with OHRP” session Nov. 14 at Public Responsibility in Medicine and Research’s Advancing Ethical Research conference in Anaheim, Calif.

From: Politico

With help from Marianne LeVine and Cogan Schneier

WHITE HOUSE ISSUES FALL REG AGENDA: The White House issued its fall regulatory agenda Thursday. Typically this document describes timelines for future rulemakings, but with a new administration on the way, all bets are off. Still, we learned a bit about what the Obama Labor Department’s priorities will be between now and Jan. 20 (and what it hopes Trump’s Labor Department’s priorities will be after):

— Beryllium rule:

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From: Association for the Advancement of Medical Instrumentation

From: Lexology

Lauren A. Tetenbaum |  Greenberg Traurig LLP

As reported, in December 2015, USCIS published a proposed rule on the Federal Register in which the Department of Homeland Security (DHS) seeks to improve job portability for highly skilled immigrants and clarify issues affecting foreign nationals in employment-based nonimmigrant visa categories like H-1B. The proposed regulations received almost 28,000 comments. On October 24, 2016, the rule was submitted to the Office of Management and Budget for final review.

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From: Biodiesel Magazine

By Erin Voegele

On Oct. 19, the U.S. EPA delivered its proposed rule to set renewable fuel standard (RFS) volumes for 2017 and biomass-based diesel volumes for 2018 to the White House Office of Management and Budget. OBM review marks a last step before a final rule is issued.

The proposed rule was first issued by EPA on May 18. It aims to set RFS renewable volume obligations (RVOs) for 2017, along with the 2018 RVO for biomass-based diesel. In the proposed rule, the agency suggested setting the 2017 RVO for advanced biofuel at 4 billion ethanol-equivalent gallons, or 2.67 biodiesel-equivalent gallons, cellulosic biofuel at 312 million gallons, and total renewable fuel at 18.8 billion gallons. The 2018 RVO for biomass-based diesel has been proposed at 2.1 billion gallons.

Editor’s Note: NHTSA’s proposed tire rating system will need to comply with the Data Quality Act.

From: Tire Review

It’s been years in the making, but finally rulemaking to empower consumers with a “tire rating system” is under review.

The NHTSA’s rulemaking to provide consumers with information about tire fuel efficiency, wet traction and tread wear is now being reviewed by The White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OMB/OIRA).

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From: Weekly Standard

A Department of Education proposal gets closer to being a reality.

By Alice B. Lloyd

The Department of Education’s proposal to broaden the existing borrower defense to repayment rule will give college students new grounds to sue their schools for loan forgiveness. Underemployed grads and downtrodden dropouts can claim they were misled and never got their federally loaned money’s worth. But the biggest problem with the proposal is the price tag. Indeed, the potential cost to taxpayers is virtually inestimable in its vastness: somewhere between two and 43 billion dollars, according to the Office of Management and Budget.

From: American Action Forum

Sam Batkins

From: The National Law Review

Article By Lynn L. Bergeson, Carla N. Hutton

. . . EPA proposed to require persons that manufacture or process certain chemical substances when manufactured or processed at the nanoscale to report electronically to EPA certain information, including the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects.  EPA also proposed to require any persons who intend to manufacture or process chemical substances as discrete nanoscale materials after the effective date of the final rule to notify EPA of the same information at least 135 days before the intended date of commencement of manufacture or processing. . . .