Regulatory Transactions

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.

The attached letter from Winslow Sargeant, Chief Counsel for Advocacy to OIRA Administrator Sunstein provides SBA’s views in response to OMB’s “Request for Information on Federal Participation in the Development and Use of Voluntary Consensus Standards and In Conformity Assessment Activities.”  In the letter, Advocacy urged OMB to inlcude in Circular A-119 guidance on consideration of small entity interests through the Regulatory Flexibility Act (RFA).

The RFA requires federal agencies to assess the impact of their regulatory proposals on small entities and consider significant alternatives that are feasible, meet the agencies objectives, and minimize the burden on small entities. Advocacy recommends the following to enhance agency RFA compliance when using private technical standards in rulemaking: