In May 2008, the Bush administration listed the polar bear as a threatened species under the Endangered Species Act (ESA). On December 16, 2008, the U.S. Fish and Wildlife Service (FWS) issued an interim special rule for management of the polar bear under § 4(d) of the ESA. Both the listing and interim special rule… Continue Reading
Monthly Archives: April 2012
Commercial Satellites: Report to Congress Recommends the Relaxation of Export Controls
The Department of Defense and Department of State released a long-awaited joint report to Congress on April 18, 2012 recommending the relaxation of export controls currently applicable to certain types of commercial satellites, satellite components and related systems. The so-called Section 1248 report, which was mandated by Congress under a 2009 statute, represents another significant development… Continue Reading
FDA Strategic Plan Emphasizes Food Safety Law Implementation
The Food and Drug Administration has released the final strategic plan for its Foods and Veterinary Medicine Program for 2012–2016, which will guide the agency’s food-related priorities for the foreseeable future. The plan in large part reflects FDA’s efforts to implement the Food Safety Modernization Act and leaves little doubt that FSMA implementation is the agency’s… Continue Reading
Implementing Health Care Reform Community-Based Care Options
The Department of Health and Human Services (HHS) released new rules to implement two community-based care options under Medicaid created by the Patient Protection and Affordable Care Act (PPACA): A final rule implementing the Community First Choice program, a new State plan option for providing home and community-based attendant services and supports to Medicaid beneficiaries… Continue Reading
Regulators Clarify Key Swap-Related Dodd-Frank Definitions
In a long-awaited decision, federal commodity and securities regulators approved final rules providing definitions for several key terms under the Dodd-Frank Wall Street Reform and Consumer Protection Act. In particular, the CFTC voted 4-1 and the SEC voted unanimously to adopt rules defining “swap dealer,” “security-based swap dealer,” “major swap participant,” “major security-based swap participant,” and “eligible… Continue Reading
CDRH Goes Back to the Drawing Board on Proposed Revisions to 510(k) Modification Guidance
Based on stakeholder comments raising serious concerns about a significant increase in the number of new 510(k) submissions that would be required for minor changes to 510(k)-cleared devices, CDRH Director, Jeffrey Shuren, recently signaled that the medical device center is revisiting its 27 July 2011 proposed draft guidance, 510(k) Modifications: Deciding When to Submit a… Continue Reading
Industry Waits for Some Signal That FDA Will Rethink Its Proposed Approach to Unsolicited Requests
With the comment period closed, industry stakeholders wait for some indication that FDA will rethink its approach to responding to unsolicited requests, as set forth in FDA’s draft guidance, Guidance For Industry – Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. Since release of the draft in December 2011, stakeholder… Continue Reading
FWS Considers Revising Endangered Species Act Regulations to Promote Voluntary Species Conservation
The U.S. Fish and Wildlife Service (FWS) recently published an advance notice of proposed rulemaking (ANPRM) seeking recommendations for regulatory revisions that would create incentives for landowners and others to take voluntary conservation actions in support of “candidate” species. Candidate species are not yet listed as threatened or endangered under the Endangered Species Act (ESA)… Continue Reading
Medicare Inpatient Hospital Rule for Fiscal Year 2013 Released
The Centers for Medicare & Medicaid Services (CMS) released the Hospital Inpatient Prospective Payment System (IPPS) proposed rule for fiscal year (FY) 2013 on April 24, 2011. The proposed rule addresses changes in payment rates for acute care and long-term care hospitals effective October 1, 2012, as well as revisions to the Hospital Value-Based Purchasing… Continue Reading
EU Suspends Sanctions Against Myanmar/Burma
The EU has acted on its earlier promise to respond to the reform efforts in Myanmar/Burma, and suspended all sanctions against the country, with the exception of the existing arms embargo. Approximately 500 Burmese individuals and over 800 companies in forestry, steel and iron, and extractive industries will no longer be subject to a freezing… Continue Reading
Health Care Reform Research Institute Amends Draft Research Agenda and Authorizes 50 Pilot Projects
The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors voted to amend PCORI’s draft Research Agenda. The changes were made in response to over 450 public comments, and include a clarification of PCORI’s focus on: Patient engagement and transparency; Patients with chronic conditions; Patients with rare diseases; Improving health care systems, including care coordination, access… Continue Reading
Export Control Reform Initiative: New ECCN Series
The U.S. Department of Commerce’s Bureau of Industry and Security (BIS) published a final rule on April 13, 2012 announcing a new series of Export Control Classification Numbers (ECCN 0Y521 series) on the Commerce Control List (CCL) of the Export Administration Regulations intended to capture items that warrant control on the CCL but are not yet identified… Continue Reading
HHS Taking Comments on New Process to Enroll in Certain Health Programs
The Department of Health and Human Services (HHS) has opened a 30-day public comment period on its proposed project to evaluate the implementation of the Express Lane Eligibility (ELE). Through ELE, state Medicaid or Children’s Health Insurance Programs (CHIP) can enroll individuals in the program based on other agencies’ findings of eligibility, even if those agencies… Continue Reading
Government Turns Up the Heat on the Oil Markets
This week saw a couple of major developments concerning the oil markets. On Tuesday, President Obama announced his intention to seek additional resources and legal authority for federal authorities to limit speculation and curb manipulation in the crude and refined products markets. Separately, on Thursday, the Southern District of New York issued an order approving a… Continue Reading
EPA Enforces Violations of the Lead Renovation, Repair and Painting Rule
The EPA recently announced three enforcement actions for violations of the Lead Renovation, Repair and Painting rule. According to EPA’s Press Release, the enforcement actions were against an owner of rental apartments in Maine, a window and siding company in New Jersey, and a home repair company in Nebraska. Cumulatively, the defendants agreed to pay over… Continue Reading
Expedited Review of Certain Immigration Cases
Companies that file immigration petitions on behalf of non-US employees will welcome the news that the U.S. Citizenship and Immigration Services has established an expedited case review process to allow for the review and subsequent correction of certain adverse decisions. Specifically, USCIS will accept requests for expedited review of petitions or applications that were rejected or denied… Continue Reading
IRS Addresses Health Plan Fees Imposed to Fund PCORI
On April 12, 2012, the IRS released a proposed rule regarding the fee imposed on health plans by the Patient Protection and Affordable Care Act (PPACA) to fund the Patient-Centered Outcomes Research Institute (PCORI). Under PPACA, this fee must be equal to the amount of covered lives in a policy year, and is to go… Continue Reading
Political Activity in the Age of the Super PAC
In the aftermath of Citizens United v. The Federal Election Commission, and related legal developments, corporations have more freedom to engage in the election process. In Citizens United, a divided Court ruled that corporations may make unlimited independent expenditures to persuade voters to support or oppose particular federal candidates as long as the expenditures are… Continue Reading
Supreme Court Declines to Review Appeal by Christian Student Groups
On March 19, the Supreme Court announced, without comment, that it would not hear an appeal from two religious student groups challenging San Diego State University’s decision not to grant official recognition to the groups. In Alpha Delta Chi-Delta Chapter v. Reed, the student groups had argued that the university violated their First Amendment rights… Continue Reading
PCORI Finalizes “Patient-Centered Outcomes Research” Definition
Section 6301 of the Patient Protection and Affordable Care Act established the Patient-Centered Outcomes Research Institute (PCORI), an independent nonprofit organization charged with conducting and disseminating comparative clinical-effectiveness research to help patients, providers, purchasers, and policy-makers reach more informed decisions. On March 5, 2012, the PCORI board of governors voted to finalize a revised definition of… Continue Reading
New Canadian Framework for 700 MHz and 2500 MHz Auctions
Industry Canada has released its Policy and Technical Framework (Framework) for the upcoming auction of spectrum in the 700 and 2500 MHz bands. Notice of the publication was published in the Official Gazette on March 24, 2012. Back in November, when Industry Canada was seeking comments for this framework, we wrote: “the issue of how much… Continue Reading
OMB Proposes Long-Awaited Federal Grant Reforms, Seeks Public Comments
On February 28, 2012, the Office of Management and Budget published a long-awaited Advance Notice of Proposed Guidance (ANPG) titled Reform of Federal Policies Relating to Grants and Cooperative Agreements; Cost Principles and Administrative Requirements (Including Single Audit Act). The sponsored research community was cautiously hopeful that the proposed reforms would yield meaningful reductions in… Continue Reading
Hogan Lovells Comments on the FDA’s “Draft Guidance on Responding to Unsolicited Requests”
The FDA issued its Draft “Guidance for Industry: Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices” in December 2011. As our FDA group follows these issues closely on behalf of the industry, we filed a Comment on this draft guidance encouraging the agency to reconsider and clarify certain elements of the Draft Guidance,… Continue Reading
Electric Industry Pro Joins Hogan Lovells’ Energy Practice
Steven Agresta has joined the firm’s Energy practice group as Of Counsel. Steven has more than 30 years of experience in the electric power industry during which he has dealt with virtually all of the issues that have challenged the industry. Prior to joining Hogan Lovells, Steven served as Executive Vice President-Legal at Entergy Services in which… Continue Reading