Search Results Archives: November 2016

November 22, 2016

Obama Administration Still Wants to Release New Common Rule

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

By Jeannie Baumann


“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.

November 18, 2016

White House Fall Reg Agenda

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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November 2, 2016

Divergent Views Expressed at FDA’s Third-Party Service Workshop

From: Association for the Advancement of Medical Instrumentation

For many in the healthcare industry, the most polarizing debate this fall has not been who should win the White House, but how far the Food and Drug Administration (FDA) ought to go in regulating the service and repair of medical devices. Last week, these divergent views came to a head during the agency’s two-day workshop on the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices by third-party entities and original equipment manufacturers (OEMs).

November 1, 2016

Update on DHS Proposed Rules Affecting Employment-based Immigrant and Nonimmigrant Visa Programs

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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