June 17, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is confirming the effective date of April 27, 2010, for the final rule that appeared in the Federal Register of March 26, 2010. The final rule amended the color additive regulations by increasing the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 12, 2010, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of HTC Corp. of Taiwan. A supplemental letter was filed on June 3, 2010. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain portable electronic devices and related software by reason of infringement of certain claims of U.S. Patent Nos. 6,999,800; 5,541,988; 6,058,183; 6,320,957; and 7,716,505. The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.

Section 101(c) of the Federal Mine Safety and Health Act of 1977 and 30 CFR part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification filed by the parties listed below to modify the application of existing mandatory safety standards published in Title 30 of the Code of Federal Regulations.

The Coast Guard is establishing a temporary safety zone in the navigable waters of Weber Point off Stockton, CA in support of a July 4th fireworks display. This safety zone is established to ensure the safety of participants and spectators from the dangers associated with the pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or his designated representative.

The Coast Guard is establishing a temporary safety zone on East Moran Bay, Lake Huron, St. Ignace, MI. This zone is intended to restrict vessels from a portion of Lake Huron during the Festivals & Fireworks Celebration fireworks display taking place on ten separate occasions from June 26, 2010 through September 5, 2010. This temporary safety zone is necessary to protect spectators and vessels from the hazards associated with fireworks displays.

The Coast Guard is establishing a temporary safety zone in the navigable waters of Suisun Bay off Pittsburg, CA in support of a July 4th fireworks display. This safety zone is established to ensure the safety of participants and spectators from the dangers associated with the pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or his designated representative.

The Federal Retirement Thrift Investment Board (Agency) proposes to amend its regulations at 5 CFR part 1600. These changes implement the Agency's automatic enrollment program as authorized by the Thrift Savings Plan Enhancement Act of 2009.

Pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4332(2)(C), the National Park Service (NPS), lead agency, along with cooperating agencies, the U.S. Forest Service (USFS) and U.S. Army Corps of Engineers, are preparing an Environmental Impact Statement (EIS) and conducting public scoping meetings for construction and right-of-way permits requested from the agencies by PATH Allegheny Transmission Company, LLC; PATH Allegheny Virginia Transmission Corporation; Potomac Edison Company; and PATH West Virginia Transmission Company, LLC, collectively referred to herein as Applicants. The Applicants are seeking permits for proposed construction of a new 765kV electric transmission line that would cross federal lands within Maryland, West Virginia, and Virginia. In May 2009, the Applicants submitted right-of-way applications (Form 299) for those portions of the PATH project proposed to traverse Harpers Ferry NHP, Chesapeake and Ohio Canal NHP, Appalachian NST, Potomac Heritage NST, all managed by the National Park Service; and Monongahela National Forest managed by the U.S. Forest Service. These applications also serve as the application for Special Use Permits for construction of the proposed project.

This notice announces the timeframe to submit pre-applications for section 514 Farm Labor Housing (FLH) loans and section 516 FLH grants for the construction of new off-farm FLH units and related facilities for domestic farm laborers. The intended purpose of these loans and grants is to increase the number of available housing units for domestic farm laborers. This notice describes the method used to distribute funds, the application process, and submission requirements.

The Presidential Commission for the Study of Bioethical Issues (Amy Gutmann, PhD, Chair, and James Wagner, PhD, Vice Chair), will conduct its first meeting to discuss the implications of synthetic biology.

Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces the Agricultural Marketing Service's (AMS) intention to request approval from the Office of Management and Budget, for an extension of and revision to the currently approved information collection in support of the Fair and Equitable Tobacco Reform Act of 2004 (U.S.C. Chapter 518), the Rural Development, Food and Drug Administrative, and Related Agencies Appropriations Act for 2002 (Appropriations Act), and the Tobacco Inspection Act and Regulations Governing the Tobacco Standards.

This rule changes the reporting and assessment date requirements prescribed under the marketing order regulating the handling of sweet onions grown in the Walla Walla Valley of southeast Washington and northeast Oregon. The marketing order is administered locally by the Walla Walla Sweet Onion Marketing Committee (hereinafter referred to as the ``Committee''). This rule revises the submission due date for certain handler reports and assessment payments from September 1 to September 30. This change allows handlers additional time to compile requisite information and submit it to the Committee. It is expected that this action will improve handler compliance with the administrative requirements of the marketing order.

The Department of Transportation (DOT), Office of the Secretary of Transportation, announces a meeting of the FAAC Environment Subcommittee, which will be held at the office of The Boeing Company in Arlington, Virginia. This notice announces the date, time, and location of the meeting, which will be open to the public. The purpose of the FAAC is to provide advice and recommendations to the Secretary of Transportation to ensure the competitiveness of the U.S. aviation industry and its capability to manage effectively the evolving transportation needs, challenges, and opportunities of the global economy. The Environment Subcommittee is charged with examining steps and strategies that can be taken by aviation-sector stakeholders and the Federal Government to reduce aviation's environmental footprint and foster sustainability gains in cost-effective ways. This includes consideration of potential approaches to promote effective international actions through the International Civil Aviation Organization.

Comments are requested on the proposed Base (1% annual-chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.

This notice amends the notice of a major disaster declaration for the State of West Virginia (FEMA-1881-DR), dated March 2, 2010, and related determinations.

The Food and Drug Administration (FDA) is announcing a 2-day public meeting to obtain input on issues and challenges associated with the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs and biological products. As FDA has taken steps to implement the REMS provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), some stakeholders have raised concerns about the impact of various REMS, and the growing number of REMS on the health care system, as well as on individual prescribers, pharmacists, distributors, and other affected stakeholders. To obtain public input about the REMS program and its impact, and to gather additional input on a draft guidance for industry issued on October 1, 2009 entitled ``Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,'' FDA has decided to hold this public meeting. FDA wishes to give a wide range of stakeholders the opportunity to provide input in this area, and will take the information it obtains from the meeting into account in its implementation of the REMS program and in the development of the final guidance and future REMS guidances.

The Environmental Protection Agency (EPA) Region 8 is issuing a Notice of Intent to Delete portions of the On-Post Operable Unit (OU3), specifically the Central and Eastern Surface Areas including surface media and structures (CES), and the surface media of the entire Off-Post Operable Unit (OU4) (OPS) of the Rocky Mountain Arsenal Federal Facility (RMA) from the National Priorities List (NPL) and requests public comment on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Colorado, through the Colorado Department of Public Health and Environment (CDPHE), have determined that all appropriate response actions at these identified parcels under CERCLA, other than operation, maintenance, and five-year reviews, have been completed. However this deletion does not preclude future actions under Superfund.

We are quarantining the States of Florida and Georgia, Puerto Rico, the U.S. Virgin Islands, two parishes in Louisiana, and two counties in South Carolina due to the presence of citrus greening and quarantining Alabama, Florida, Georgia, Guam, Hawaii, Louisiana, Mississippi, Puerto Rico, Texas, the U.S. Virgin Islands, three counties in South Carolina, portions of one county in Arizona, and all of three and portions of an additional three counties in California due to the presence of Asian citrus psyllid, a vector of the bacterial pathogen that causes citrus greening. This action follows the discovery of these pests in the respective quarantined areas. We are also establishing restrictions on the interstate movement of regulated articles from the quarantined areas. This action is necessary on an emergency basis in order to prevent the spread of the disease and its vector to noninfested areas of the United States.

Elsewhere in this issue of the Federal Register, the IRS is issuing temporary regulations under the provisions of the Patient Protection and Affordable Care Act (the Affordable Care Act) dealing with rules relating to status as a grandfathered health plan. The IRS is issuing the temporary regulations at the same time that the Employee Benefits Security Administration of the U.S. Department of Labor and the Office of Consumer Information and Insurance Oversight of the U.S. Department of Health and Human Services are issuing substantially similar interim final regulations with respect to group health plans and health insurance coverage offered in connection with a group health plan under the Employee Retirement Income Security Act of 1974 and the Public Health Service Act. The temporary regulations provide guidance to employers, group health plans, and health insurance issuers providing group health insurance coverage. The text of those temporary regulations also serves as the text of these proposed regulations.

The Coast Guard proposes to harmonize its regulations with International Maritime Organization (IMO) amendments to Chapter VI and Chapter VII to the International Convention for the Safety of Life at Sea, 1974, as amended, (SOLAS) that make the International Maritime Solid Bulk Cargoes (IMSBC) Code mandatory. The amendments require that all vessels subject to SOLAS and carrying bulk solid cargoes other than grain must comply with the IMSBC Code. The Coast Guard proposes to amend its regulations governing the carriage of solid hazardous materials in bulk to allow use of the IMSBC Code as an equivalent form of compliance for all domestic and foreign vessels operating in U.S. navigable waters. Proposed changes to the Coast Guard regulations will also expand the list of solid hazardous materials authorized for bulk transportation by vessel and include special handling procedures based on the IMSBC Code and existing special permits. These proposed changes would reduce the need for the current special permits for the carriage of certain solid hazardous materials in bulk.