Category Archives: Advocacy and Regulations

Washington Update and 2014 Preview

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Despite the partisan battles that have led to near constant gridlock in the Capitol over the past few years, lawmakers ended 2013 on a positive note. Democrats and Republicans were able to overcome their differences to produce a bipartisan compromise on the federal budget, helping to alleviate the threat of another government shutdown and providing some sequestration relief. As Congress moves into 2014, this newfound bipartisanship will be put to the test when legislators must pass an omnibus appropriations bill to fund the government by January 15 and agree to raise the debt ceiling by spring.  Aside from fiscal issues, Washington saw movement on healthcare issues—including proposals to permanently replace the Sustainable Growth Rate (SGR)—while progress moved at a slower pace on other key initiatives like tax reform and the Farm Bill.Continue reading→

OMB releases Federal Grant Reform Guidance developed by COFAR

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As 2013 came to a close, on December 26, 2013, the Office of Management Budget (OMB) issued the long-awaited final rule to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, more commonly known as the “Super Circular.” This rule finalizes OMB’s proposed guidance from February 1, 2013, and represents the culmination of an effort that was more than two years in the making. Among other things, this rule streamlines eight Federal regulations (including OMB Circulars A-110, A-122, and A-133) into a single, comprehensive policy guide and affords the Federal government the ability to better administer the $600 billion awarded annually for grants, cooperative agreements, and other types of financial assistance. This will have important implications for all nonprofit recipients of, and applicants for, Federal grants and cooperative agreements (“awards”). (Source and Super Circular summary:  Venable, LLP)

 

(NSF Video: http://youtu.be/xBmjulDwDWk)

To assist organizations in understanding the final rule, OMB  hosted an informational webcast on December 20, 2013 with team members from  COFAR agencies. The recorded webcast is shown above.  For more information visit www.cfo.gov/cofar.

To view the Super Circular, click here.

While effective December 26, 2013, actual  roll out by agencies will continue throughout 2014.  It will be imperative for nonprofit organizations to assess their current practices and policies and take appropriate steps to ensure that they conform with the final rule in a timely manner.

 

FTC Seeking Public Comment on Follow-On Biologics

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The Federal Trade Commission (FTC) is seeking public comment on follow-on biologics.

In addition, the FTC will hold a public workshop on December 1oth.

The Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition

The  Federal Trade Commission announces it will hold a workshop to explore  competition issues involving biologic medicines and follow-on biologics. As  described in the Federal Register Notice, the workshop will focus on a few key  issues, inter alia:

  • The potential impact of state regulations affecting competition.
  • How regulations, if necessary, might be structured to facilitate competition  while still protecting patient health and safety.
  •   How naming may affect competition.
  • The experience of other countries with follow-on biologic competition.

The  Federal Register Notice poses a series of questions about which the FTC seeks  public comment. The FTC will take these comments into account in its  examination of these topics.

Previous Biologics Workshops and Report:

Event Details

WHEN:

December 10, 2013 Time: 9am – 5pm

WHERE:

FTC Conference Center

601 New Jersey Avenue, NW

Washington, DC

Learn more at http://www.ftc.gov/opp/workshops/biologics/#nj

SEC Releases Crowd Funding Rules for Non-Accredited Investors Under the JOBS Act.

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On October 25, 2013, The Securities and Exchange Commission (SEC) released the Proposed Rules to govern the implementation of crowd funding by non-accredited investors under the JOBS Act.   Comments will be open for a 90 day  public comment period from the date that the proposed regs appear on the Federal Register. (As of this writing, the proposed regs have not yet been posted.) Continue reading→