Regulatory Transactions

Editor’s Note: FireceBiotech reports that “an NIH-sponsored study of Gilead’s sofosbuvir combined with ribavirin demonstrated that the experimental therapy provided a ‘safe and effective’ interferon-free approach for even some of the toughest hepatitis C cases.”

From: FierceBiotech

By John Carroll

So what happens at the FDA in the event of a government shutdown next Tuesday? For now, the agency isn’t saying, referring reporters to an OMB statement guiding government agencies to prepare to execute “an orderly shutdown.”

From: RegWatch — The Hill’s Regulation Blog

By Ben Goad

The Environmental Protection Agency (EPA) neglected to take small businesses into consideration during the development of regulations with major implications for land development, a powerful industry group charged Tuesday.

The National Federation of Independent Business (NFIB) is sending a letter Tuesday to the White House Office of Information and Regulatory Affairs (OIRA), demanding that the draft regulations be returned to the EPA for additional analysis.

“EPA plainly has not met its obligations to understand how this rule will affect small businesses,” the letter contends.

From: RegBlog

Jenna Shweitzer

The majority of chemicals in use today have not been screened for safety or regulated under the Toxic Substances Control Act (TSCA), making the Act considered to be largely ineffective. The proposed Chemical Safety Improvement Act (CSIA) would revamp and modernize TSCA by requiring all existing and new chemicals to be screened for safety and then regulated if necessary.

Introduced by the late Senator Lautenberg (D-NJ) and Senator Vitter (R-LA), the CSIA appears to have considerable bipartisan support, having won praise from both industry and environmental advocates. Although the CSIA is viewed by many as an improvement over TSCA, some argue that the bill does not go far enough to protect human health and the environment.

From: Bloomberg/BNA

By Amena H. Saiyid

A proposed rule sent to the White House for interagency review Sept. 17 aims to clarify which waters and wetlands are protected under the Clean Water Act.

The rule from the Environmental Protection Agency and the Army Corps of Engineers would provide greater clarity about which waters are subject to Clean Water Act jurisdiction and greater certainty about which activities require Clean Water Act permits, senior EPA officials wrote in a blog post.

For instance, the rulemaking would indicate when dredge-and-fill activities as well as discharges of pollutants would be subject to Clean Water Act protections.

From: FierceHealthIT

By Susan D. Hall

What’s taking so long? That’s what four members of the U.S. House asked in a recent letter to the Office of Management and Budget about releasing the Unique Device Identifier (UDI) final rule.

In response to slow progress, Congress last year set a June 19 deadline for  the Food and Drug Administration to develop regulations for a medical device tracking system. The FDA’s proposed rule has been under review with the OMB–the  final step–for nearly a full year.

From: Benefits Pro

DOL fiduciary revamp won’t be ready in October

By Melanie Waddell

Wall  Street  Journal

 Keith Johnson and Tennille Tracy

Agency Ready to Require Costly, Novel Equipment to Capture Greenhouse Emissions

WASHINGTON—The Obama administration plans to block the construction of new coal-fired power plants unless they are built with novel and expensive technology to capture greenhouse-gas emissions, according to people familiar with a draft proposal.

The administration’s rule on emissions from new power plants, a long-awaited measure that is one of the capstones of the administration’s climate-change agenda, is set to be formally proposed by the end of next week. While the new rule isn’t final yet and is likely to face a legal challenge, it would be another blow to a coal industry already buffeted by a bonanza of cheap natural gas and increasing regulation.

From: iHealthBeat

HHS’ Office for Civil Rights has sent a proposed rule to the Office of Management and Budget that would ease legal barriers under HIPAA that prevent some states from reporting certain medical data to a federal gun-purchase background check database, Health Data Management reports.

OMB review is one of the last steps before a rule is published in the Federal Register (Goedert, Health Data Management, 9/9).

Background on Database

The National Instant Criminal Background Check System, or NICS, is used by gun dealers to ensure they are not selling weapons to individuals who are prohibited from owning firearms, such as people with substance use disorders and those with severe mental health issues.

From: Huffington Post/Politics

Editor’s Note:  For more on the significance of bad data, see Washington Post here.

From: The Washington Post

By Kimberly Kindy

The USDA has used incomplete and antiquated data in support of its plan to extend new poultry inspection procedures to plants across the country, according to a report by the Government Accountability Office scheduled for public release on Wednesday.

As a result, there are “questions about the validity” of the USDA’s conclusions that the procedures, now used by a limited number of poultry plants under a pilot program, are more effective than the traditional approach at reducing pathogens such as salmonella, the GAO found.