August 3, 2011 – Federal Register Recent Federal Regulation Documents

This document contains amendments to the interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding preventive health services.

NMFS announces that it is establishing a new control date of March 11, 2011, to control future access to the commercial wreckfish sector of the snapper-grouper fishery operating in the exclusive economic zone (EEZ) of the South Atlantic. If changes to the management regime are developed and implemented under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), a control date could be used to limit the number of participants in this commercial sector. This announcement is intended, in part, to promote awareness of the potential eligibility criteria for future access so as to discourage speculative entry into this sector while the South Atlantic Fishery Management Council (Council) and NMFS consider whether and how access to the commercial wreckfish sector should be controlled.

This final rule addresses recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB) on November 5, 2009, and April 29, 2010. The recommendations addressed in this final rule pertain to the continued exemption (use) of 12 substances in organic production and handling. Consistent with the recommendations from the NOSB, this final rule continues the exemption (use) of 12 substances (along with any restrictive annotations) on the U.S. Department of Agriculture's (USDA) National List of Allowed and Prohibited Substances (National List).

The Federal Energy Regulatory Commission (Commission) proposes to amend the instructions on page 700 of FERC Form No. 6 (Form 6) to ensure that pipelines report interstate-only barrel and barrel-mile data and not a combination of interstate and intrastate throughput. The Commission also proposes to direct pipelines that reported combined interstate and intrastate data on lines (1) through (12) of page 700 of their 2010 Form 6 to file a revised page 700 containing only interstate data for the years 2009 and 2010.

The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule on the ``gluten-free'' labeling of foods, published in the Federal Register of January 23, 2007 (72 FR 2795). In that document, FDA proposed to define the term ``gluten- free,'' for voluntary use in the labeling of foods, to mean that the food does not contain an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as ``prohibited grains''); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or 20 ppm or more gluten. FDA also announced in the proposed rule that we intended to conduct a safety assessment for gluten exposure and seek comments on the safety assessment and its potential use in defining the term ``gluten-free'' in the final rule. A report by FDA discussing a health hazard assessment we conducted, which included a safety assessment for gluten exposure in individuals with celiac disease, has been peer reviewed by an external group of scientific experts, and we revised the assessment, as appropriate, based upon expert comments. FDA is reopening the comment period for the proposed rule on the ``gluten- free'' labeling of foods to, in part, announce the availability of and solicit comments on the report entitled ``Health Hazard Assessment for Effects of Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten'' (``Gluten Report''), which discusses the Agency's gluten safety assessment. The Agency also seeks comments on whether and, if so, how, the safety assessment should affect FDA's proposed definition of ``gluten-free'' in the final rule, and on a number of related issues. Finally, FDA seeks comments on the Agency's tentative conclusions that the safety assessment-based approach may lead to a conservative, highly uncertain estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure; and that the final rule should adopt the proposed rule's approach to defining the term ``gluten-free,'' because that approach takes into account the availability of reliable analytical methods and also considers other practical factors related to the needs of individuals with celiac disease and their food consumption.

This document provides notice of public hearing on proposed rulemaking providing guidance on the indoor tanning services excise tax imposed by the Patient Protection and Affordable Care Act. These regulations affect users and providers of indoor tanning services.

On June 3, 2010, FEMA published in the Federal Register a proposed rule that contained an erroneous table. This notice provides corrections to that table, to be used in lieu of the information published at 75 FR 31373. The table provided here represents the flooding sources, location of referenced elevations, effective and modified elevations, and communities affected for Lawrence County, Missouri, and Incorporated Areas. Specifically, it addresses the following flooding sources: Chapel Drain, Clear Creek, Kelly Creek Tributary, Tributary No. 1, Tributary 2, Unnamed Tributary, Unnamed Tributary Number 1, Unnamed Tributary Number 2, Unnamed Tributary Number 3, and Unnamed Tributary Number 4.

On May 25, 2010, FEMA published in the Federal Register a proposed rule that contained an erroneous table. This notice provides corrections to that table, to be used in lieu of the information published at 75 FR 29290. The table provided here represents the flooding sources, location of referenced elevations, effective and modified elevations, and communities affected for Anne Arundel County, Maryland, and Incorporated Areas. Specifically, it addresses the following flooding sources: Cabin Branch, Franklin Branch, Hall Creek, Little Patuxent River, Marley Creek, Midway Branch, Patapsco River, Patuxent River, Sawmill Creek, and Severn Run.

This proposed rule reflects the Centers for Medicare and Medicaid Services' commitment to the general principles of the President's Executive Order 13563 released January 18, 2011, entitled ``Improving Regulation and Regulatory Review,'' as this rule would: implement a new reconsideration process for administrative determinations to disallow claims for Federal financial participation (FFP) under title XIX of the Act (Medicaid); lengthen the time States have to credit the Federal Government for identified but uncollected Medicaid provider overpayments and provide that interest will be due on amounts not credited within that time period; make conforming changes to the Medicaid and Children's Health Insurance Program (CHIP) disallowance process to allow States the option to retain disputed Federal funds through the new administrative reconsideration process; revise installment repayment standards and schedules for States that owe significant amounts; provide that interest charges may accrue during the new administrative reconsideration process if a State chooses to retain the funds during that period. This proposed rule would also make a technical correction to reporting requirements for disproportionate share hospital payments, revise internal delegations of authority to reflect current CMS structure, remove obsolete language, and correct other technical errors.

The Securities and Exchange Commission (``Commission'') is adopting new Rule 13h-1 and Form 13H under Section 13(h) of the Securities Exchange Act of 1934 (``Exchange Act'') to assist the Commission in both identifying, and obtaining trading information on, market participants that conduct a substantial amount of trading activity, as measured by volume or market value, in the U.S. securities markets. Rule 13h-1 will require a ``large trader,'' defined as a person whose transactions in NMS securities equal or exceed 2 million shares or $20 million during any calendar day, or 20 million shares or $200 million during any calendar month, to identify itself to the Commission and make certain disclosures to the Commission on Form 13H. Upon receipt of Form 13H, the Commission will assign to each large trader an identification number that will uniquely and uniformly identify the trader, which the large trader must then provide to its registered broker-dealers. Such registered broker-dealers will then be required to maintain records of two additional data elements in connection with transactions effected through accounts of such large traders (the large trader identification number, and the time transactions in the account are executed). In addition, the Commission is requiring that such broker-dealers report large trader transaction information to the Commission upon request through the Electronic Blue Sheets systems currently used by broker-dealers for reporting trade information. Finally, certain registered broker-dealers subject to the Rule will be required to perform limited monitoring of their customers' accounts for activity that may trigger the large trader identification requirements of Rule 13h-1. The large trader reporting requirements are designed to provide the Commission with a valuable source of useful data to support its investigative and enforcement activities, as well as facilitate the Commission's ability to assess the impact of large trader activity on the securities markets, to reconstruct trading activity following periods of unusual market volatility, and to analyze significant market events for regulatory purposes.

Under section 5(a)(2) of the Toxic Substances Control Act (TSCA), EPA is proposing to amend the significant new use rule (SNUR) for the chemical substance identified generically as tris carbamoyl triazine, which was the subject to premanufacture notice (PMN) P-95- 1098. This action would amend the SNUR to allow certain uses without requiring a significant new use notice (SNUN), and would extend SNUN requirements to certain additional uses. EPA is proposing this amendment based on review of new toxicity test data.

The Fish and Wildlife Service (Service) has developed regulations that would authorize the nonlethal, incidental, unintentional take of small numbers of polar bears and Pacific walruses during year-round oil and gas industry (Industry) exploration, development, and production operations in the Beaufort Sea and adjacent northern coast of Alaska. Industry operations for the covered period include types of activities similar to those covered by the previous 5- year Beaufort Sea incidental take regulations that were effective from August 2, 2006, through August 2, 2011. We find that the total expected takings of polar bears and Pacific walruses during oil and gas industry exploration, development, and production activities will have a negligible impact on these species and will not have an unmitigable adverse impact on the availability of these species for subsistence use by Alaska Natives. We base this finding on the results of 17 years of data on the encounters and interactions between polar bears, Pacific walruses, and Industry; recent studies of potential effects of Industry on these species; oil spill risk assessments; potential and documented Industry impacts on these species; and current information regarding the natural history and status of polar bears and Pacific walruses. This rule is effective for 5 years from date of issuance.