An archive is an accumulation of historical records – in any media – or the physical facility in which they are located. Archives contain primary source documents that have accumulated over the course of an individual or organization’s lifetime, and are kept to show the function of that person or organization.
September 10, 2021
July 18, 2019
July 10, 2019
How FDA is Regulating E-Cigarettes
From: FDA
By: Ned Sharpless, M.D., Acting Commissioner
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Under the PMTA pathway, FDA evaluates a new tobacco product based on whether it is appropriate for the protection of the public health. Scientific evaluation considers the risks and benefits of the product for the whole population, including users and non-users. These data should show the increased or decreased likelihood that current tobacco users will stop using certain products, as well as the increased or decreased likelihood that non-users will start using the products.
Before and After OIRA Review Versions Provided for Proposed GILTI Regs
From: Taxnotes
Citations: REG-101828-19
SUMMARY BY TAX ANALYSTSThe following text is an unofficial redline comparison of proposed regulations (REG-101828-19) that provide guidance on stock ownership rules and global intangible low-taxed income and a draft versionof the regs before they were submitted for review by the White House Office of Information and Regulatory Affairs.
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See complete document (paywall)
June 27, 2019
The Trump administration is quietly helping people get kidneys
From: Vox
Two new rules could make sure more kidneys go to recipients who need them.
June 21, 2019
Key Trump proposal to lower drug prices takes step forward
From: The Hill
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The Department of Health and Human Services (HHS) sent to the White House for review a proposal to lower certain drug prices in Medicare by linking them to the lower prices paid in other countries, an idea called the international pricing index.
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It is unclear how long the process of White House review will take, and whether the White House will seek to make significant changes to the proposal
June 17, 2019
Federal Government Violated The Law In Marijuana Scheduling Evaluation, Group Says
Editor’s Note: For a history of the use of the DQA to seek relief from federal dissemination of inaccurate information concerning the medical use of cannabis, see Americans for Safe Access Data Quality Act Briefs and Replies. To see the power of the DQA to change a DEA scheduling decision, see Jim Tozzi’s Role in Stopping the DEA from Classifying Drug in Schedule 1 Status.
From: Marijuana Moment
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June 11, 2019
OMB Reviewing OIG Proposed Rule Amending Federal Anti-kickback and Beneficiary Inducement Policies to Promote Value-Based Care
From: Lexology
Elizabeth B. Carder-Thompson and Debra A. McCurdy | Reed Smith LLP
The White House Office of Management and Budget (OMB) is reviewing a long-awaited Trump Administration proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute to better support coordinated care. The proposed rule presumably builds on the related request for information (RFI) on this topic issued by the Office of Inspector General (OIG) of the Department of Health Human Services (HHS) in August 2018. As discussed in a Reed Smith client alert, the RFI sought information on, among other things, changes needed in current safe harbors and beneficiary inducement CMPs to promote beneficial care coordination, patient engagement, and value-based arrangements.
May 29, 2019
OMB begins review of FMCSA proposal on hours-of-service rules for agricultural commodities
From: Safety + Health
Washington — The Federal Motor Carrier Safety Administration on May 17 submitted for review to the White House Office of Management and Budget an advance notice of proposed rulemakingintended to help the agency assess whether to clarify the definitions of “agricultural commodity” or “livestock” in FMCSA’s hours-of-service regulations for commercial truck drivers.
Currently, federal regulations offer an HOS exemption for drivers who transport livestock and other agricultural commodities within a radius of 150 air miles.
May 24, 2019
DOL to revisit fiduciary rule by December
Editor’s Note: See also The Future Of The Fiduciary Rule Is In OIRA’s Hands.
From: Pensions & Investments
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The agenda, published by the Office of Management and Budget’s Office of Information and Regulatory Affairs for all federal agencies, projects a December release date for advanced notice of proposed rule-making, the first step in issuing new rules.
DOL issued a revised fiduciary rule in April 2016 to replace one from 1975, but it was vacated by the 5th U.S. Circuit Court of Appeals in New Orleans in March 2018, on the grounds that it represented regulatory overreach. “The department is considering regulatory options in light of the 5th Circuit opinion,” the OMB notice said.