Regulatory Transactions

From: House Committee on Oversight and Government Reform

Committee and Subcommittee Chairmen tell Obama Administration OIRA is Duty-bound to Return Rule for Further Consideration

(WASHINGTON)—Committee on Oversight and Government Reform Chairman Darrell Issa (R-CA) and Regulatory Affairs, Stimulus Oversight and Government Spending Subcommittee Chairman Jim Jordan (R-OH) today wrote to the Obama Administration’s top regulatory review official saying the agency is obligated to further review the rules and the transparency of enactment.  They said the consequences of the Administration’s rulemaking will be reduced consumer choice—with higher costs—and serious concerns about vehicle and passenger safety in order to meet the new requirements.

CRE’s comments to OIRA on CMS’ Information Collection Request for their Durable Medical Equipment bidding program is attached here.

Key conclusions in CRE’s comments are:

• Practical Utility. The ICR does meet the Paperwork Reduction Act’s practical utility requirements since it does not meet the MMA’s goal of obtaining home medical equipment and services at competitive prices.

• Utility and Transparency.  The ICR does not meet the Data (Information) Quality Act’s utility and influential information requirements because it does not use accepted models and a transparent methodology.

From: Inside EPA

EPA and other agencies will have to test their data collection forms before releasing them to the public, according to a new requirement from the White House Office of Information & Regulatory Affairs (OIRA), which cites testing of EPA’s fuel economy label as a good example of pre-release review.

One source says the new requirement is “restating and reemphasizing” the original goal of the Paperwork Reduction Act (PRA), which was designed to reduce paperwork burdens on regulated industries.

From: Food Safety News

by Dan Flynn

That’s disappointing to some attending the International Association for Food Protection (IAFP) meeting this week at the Rhode Island State Convention Center.

The new U.S. Food Safety Modernization Act (FSMA) was passed by bipartisan majorities in Congress and signed by President Obama in January 2011, but implementation details have not been widely shared outside the federal government.

Editor’s Note: The article below discusses OMB’s modest use of longstanding Presidential regulatory review authority.

From: Washington Post

White House weakened EPA soot proposal, documents show

By Juliet Eilperin

The White House recently modified an Environmental Protection Agency proposal to limit soot emissions, according to documents obtained by The Washington Post, inviting public comment on a slightly weaker standard than the agency had originally sought.

The behind-the-scenes tweaking of the proposed soot standards, which affect particles measuring less than 2.5 micrometers in diameter, sparked criticism that the White House was interfering with science-based decisions.

Editor’s Note:  OMB’s careful review of the draft FDA regulations, despite limited staff, is deserving of praise and is important to the long term safety of the food supply.

From: Food Safety News

More Deadlines Missed as FSMA Rules Remain Stalled at OMB

Key food safety rules have now been under administration review for 6 months

by Helena Bottemiller

Food safety advocates remain frustrated and confused as central Food Safety Modernization Act rules have failed to advance more than six months after they were sent to the White House Office of Management and Budget.

Attached below is a letter from the US Chamber of Commerce to OIRA Administrator Sunstein.  The letter concludes:

The EPA study, if conducted properly, can help provide valuable insight into hydraulic fracturing. If the appropriate steps are taken to ensure a scientifically sound and credible study, there will be greater faith placed in the report. The imprimatur of the federal government bears significant weight, even when a government study fails to meet high standards. This makes the importance of implementing the highest standards even more important, so that the best science is informing public discourse and decision-making. As this critical EPA study moves forward, the Chamber will closely monitor whether EPA is following the principles that OMB itself has recognized are critical to sound science.

Editor’s Note:  OMB is to be commended for their dilligence in exercising their statutory and Presidentially-delegated authority to protect the economy from unwarrented regulatory actions.

From: Politico

By JONATHAN ALLEN and ERICA MARTINSON

This election year the EPA is toxic.

The Senate is voting on whether EPA planes can take pictures of farms — after  it was mistakenly reported that drones were flying over the heartland. House  Republicans want to cut the agency’s funding to pre-1998 levels. And the  president has threatened to veto a House bill, due up Wednesday, that would  restrict Clean Air Act rules.

From: MEDVAL

The EO 12866 regulatory review of the proposed prerule for “Medicare Secondary Payer and ‘Future Medicals’ (CMS-6047-ANPRM)” was completed today. While no publication date was listed, we should certainly be on the lookout for the long awaited publication of CMS’ latest masterpiece. In the eleven years that CMS has actively been enforcing the MSP with regard to future medicals, this is the first time that it is has done anything that will have to sustain public scrutiny. Let the games begin!

From: The Regulatory Affairs Professionals Society

By Alexander Gaffney

A proposed rule by the US Food and Drug Administration (FDA) which would implement a so-called Unique Device Identification (UDI) system has been held up at the US Office of Management and Budget (OMB) for months, but could soon see rapid adoption under proposed user fee legislation in both the Senate and House of Representatives.