September 20, 2010 – Federal Register Recent Federal Regulation Documents

Section 602 of Public Law 102-585, the ``Veterans Health Care Act of 1992'' enacted Section 340B of the Public Health Service Act (PHSA). Section 340B implements a drug pricing program by which manufacturers who sell covered outpatient drugs to particular covered entities listed in the statute must agree to charge a price that will not exceed the amount determined under a statutory formula. Section 7102 of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148) requires the Secretary of Health and Human Services (HHS) to promulgate regulations to establish and implement an administrative dispute resolution process for the 340B Drug Pricing Program (340B Program). (PHSA Section 340B(a)(5)(D) advises the Secretary on the sanctions available should a covered entity be found to be in violation of (a)(5)(A) or (a)(5)(B). The ANPRM does not currently refer to HRSA's plan on how it will resolve any decision made through the new Administrative Dispute Resolution Process and the sanctions in current law). These regulations will address a number of issues that have the potential to impact stakeholders. Accordingly, the Health Resources and Services Administration is issuing an advance notice of proposed rulemaking (ANPRM) to solicit public comment on multiple issues regarding implementation of these regulations. These comments will be used, as appropriate, to help draft a proposed rule that will be published in the Federal Register for public comments.

This proposed rule would establish opening dates and adjust quotas for the 2011 fishing season for sandbar sharks, non-sandbar large coastal sharks (LCS), small coastal sharks (SCS), and pelagic sharks. Quotas will be adjusted based on the framework established in Amendment 2 to the 2006 Consolidated Highly Migratory Species Fishery Management Plan, which requires adjustments for any over- and/or underharvests experienced during the 2009 and 2010 Atlantic commercial shark fishing seasons. In addition to establishing opening dates and adjusting annual quotas, this proposed rule analyzes adaptive management measures, such as various opening dates for the fishing season as well as allowing adjustments through inseason actions in the allowable number of fish that can be taken via trip limits, to provide flexibility in management in furtherance of equitable fishing opportunities to the extent practicable for commercial shark fishermen in all regions and areas. The proposed measures could affect fishing opportunities for commercial shark fishermen in the Atlantic and Gulf of Mexico.

This proposed rule would amend regulations of the Department of Commerce's Bureau of Economic Analysis (BEA) to set forth the reporting requirements for the BE-11, Annual Survey of U.S. Direct Investment Abroad. The survey is conducted annually and is a sample survey that obtains financial and operating data covering the overall operations of U.S. parent companies and their foreign affiliates. BEA proposes to amend the BE-11 forms and instructions to bring them into conformity with the 2009 BE-10, Benchmark Survey of U.S. Direct Investment Abroad. These amendments include changes in form design and reporting thresholds, as well as changes in the data items collected. The proposed changes also include a change in the reporting criteria for foreign affiliates with U.S. Parent (U.S. Reporter) ownership between 10 and 20 percent.

EPA is promulgating significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 25 chemical substances which were the subject of premanufacture notices (PMNs). One of these chemical substances is subject to a TSCA section 5(e) consent order issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 25 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

The State of Rhode Island has applied to EPA for final authorization of certain changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA determined that these changes satisfy all requirements needed to qualify for final authorization and recently authorized all but one of the State's changes through an immediate final rule. However, EPA also stated in that rule that it would address the authorization of the state's requirements regarding EPA's Zinc Fertilizer Rule in a separate final rule (following the proposed rule) as it anticipated possible adverse comments that would oppose the Federal authorization of Rhode Island for this particular rule. There was, in fact, an adverse comment filed objecting to EPA authorizing Rhode Island for the Zinc Fertilizer Rule. Today's action responds to that comment but does not agree with it and, thus, finalizes the Agency's decision to authorize Rhode Island for EPA's Zinc Fertilizer Rule. In addition, the comment also objected to EPA authorizing Rhode Island for the Burden Reduction Initiative. Accordingly, EPA is partially withdrawing the immediate final rule insofar as it authorized Rhode Island for the Burden Reduction Initiative. However, EPA is now responding to the comment and again not agreeing with it and, thus, today's action also authorizes Rhode Island for the Burden Reduction Initiative. No objections were filed to EPA regarding authorizing the other revisions submitted by Rhode Island. Accordingly, the immediate final rule is not being withdrawn as to these other revisions, which will continue to be authorized pursuant to the immediate final rule.

The EPA is announcing a public hearing to be held for the proposed ``Rule to Implement the 1997 8-Hour Ozone National Ambient Air Quality Standard: New Source Review Anti-Backsliding Provisions for Former 1-Hour Ozone Standard'' which published in the Federal Register on August 24, 2010. The hearing will be held on Tuesday, October 12, 2010, in Washington, DC.

The Coast Guard is establishing a temporary safety zone on the waters of Lake Sammamish, WA for the Composite Laminate Specialties (CLS) Fall Championship Hydroplane Race. This action is necessary to ensure public safety from the intrinsic dangers associated with high- speed races while ensuring unencumbered access for rescue personnel in the event of an emergency. During the enforcement period, no person or vessel will be allowed to enter the safety zone without the permission of the Captain of the Port or Designated Representative.

This rule increases the assessment rate established for the Cherry Industry Administrative Board (Board) for the 2010-2011 fiscal period from $0.0066 to $0.0075 per pound of assessable tart cherries. The Board locally administers the marketing order which regulates the handling of tart cherries grown in Michigan, New York, Oregon, Pennsylvania, Utah, Washington, and Wisconsin. Assessments upon tart cherry handlers are used by the Board to fund reasonable and necessary expenses of the program. The 2010-2011 fiscal period year begins October 1, 2010. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.

On February 24, 2010, the State of Alabama, through the Alabama Department of Environmental Management (ADEM), submitted a request to EPA to make a determination that the Birmingham, Alabama, nonattainment area has attained the 24-hour fine particulate matter (PM2.5) National Ambient Air Quality Standard (NAAQS) based on quality assured, quality controlled monitoring data from 2007-2009. The Birmingham, Alabama, 2006 24-hour PM2.5 nonattainment area (hereafter referred to as ``the Birmingham Area'') is comprised of Jefferson and Shelby Counties in their entireties, and a portion of Walker County in Alabama. In this action, EPA is taking final action to determine that the Birmingham Area has attained the 2006 24-hour PM2.5 NAAQS. This clean data determination is based upon complete, quality assured, quality controlled, and certified ambient air monitoring data for the years 2007-2009 showing that the Birmingham Area has monitored attainment of the 2006 24-hour PM2.5 NAAQS.