October 19, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.

We propose to adopt a new airworthiness directive (AD) for the products listed above that would supersede two existing ADs. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

The Coast Guard is establishing a temporary safety zone in Lake Erie, Lakewood, OH for the Mainardi/Kinsey Wedding Fireworks. This temporary zone is intended to restrict vessels from a portion of Lake Erie during the Mainardi/Kinsey Wedding Fireworks on October 22, 2011. This temporary safety zone is necessary to protect spectators and vessels from the hazards associated with a firework display.

The Commodity Credit Corporation (CCC) proposes regulations with respect to general sugar inventory disposition and the establishment of a new Feedstock Flexibility Program (FFP) that requires the Secretary to purchase sugar to produce bioenergy as a means to avoid forfeitures of sugar loan collateral under the sugar loan program. These regulations are as required by the Food Security and Rural Investment Act of 2002 (the 2002 Farm Bill), as amended by the Food, Conservation, and Energy Act of 2008 (the 2008 Farm Bill).

In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing temporary regulations relating to deductions for the costs of producing film and television productions. Those temporary regulations reflect changes to the law made by the Tax Extenders and Alternative Minimum Tax Relief Act of 2008, and affect taxpayers that produce films and television productions within the United States. The text of those temporary regulations also serves as the text of these proposed regulations.

EPA is taking direct final action to approve revisions to the State Implementation Plan (SIP) submitted by the Commonwealth of Virginia. This revision establishes Virginia's transportation conformity requirements. After they have been approved, the Commonwealth's regulations will govern transportation conformity determinations in the Commonwealth of Virginia. EPA is approving these revisions in accordance with the requirements of the Clean Air Act (CAA).

EPA is proposing to approve Ohio's and Indiana's requests to redesignate their respective portions of the Cincinnati-Hamilton OH-IN- KY nonattainment area (for Ohio: Butler, Clermont, Hamilton, and Warren Counties, Ohio; for IN: a portion of Dearborn County) to attainment for the 1997 annual National Ambient Air Quality Standard (NAAQS or standard) for fine particulate matter (PM2.5). The Ohio Environmental Protection Agency (Ohio EPA) submitted its request on December 9, 2010, and the Indiana Department of Environmental Management (IDEM) submitted its request on January 25, 2011. Kentucky's request to redesignate its portion of the Cincinnati- Hamilton area, submitted to EPA to on January 27, 2011, will be addressed in a separate rulemaking action. EPA's proposal here involves several additional related actions. EPA has previously determined that the entire Cincinnati-Hamilton (OH-IN-KY) area has attained the 1997 annual PM2.5 standard. EPA is proposing to approve, as revisions to the Ohio and Indiana State Implementation Plans (SIPs), the States' plans for maintaining the 1997 annual PM2.5 NAAQS through 2021 in the area. EPA is proposing to approve the 2005 emissions inventories for the Ohio and Indiana portions of the Cincinnati-Hamilton area as meeting the comprehensive emissions inventory requirement of the Clean Air Act (CAA). Finally, EPA finds adequate and is proposing to approve Ohio and Indiana's Nitrogen Oxides (NOX) and PM2.5 Motor Vehicle Emission Budgets (MVEBs) for 2015 and 2021 for the Cincinnati-Hamilton area.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

DEA wishes to emphasize that third-party audits of software applications for Electronic Prescriptions for Controlled Substances (EPCS) must encompass all applicable requirements in our regulations, including security, and must address ``processing integrity'' as set forth in our regulations. Likewise, where questions or gaps may arise in reviewing a particular application, DEA recommends consulting federal guidelines set forth in NIST Special Publication 800-53A. DEA is also announcing the first DEA approved certification process for EPCS. Certifying organizations with a certification process approved by DEA pursuant to the regulations are posted on DEA's Web site once approved.

The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by establishing an allowable level for the chemical di(2-ethylhexyl)phthalate (DEHP). As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for DEHP at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers are also required to monitor their source water for DEHP as often as necessary, but at least once every year unless they meet the criteria for source water monitoring exemptions under the CGMP regulations. This final rule will ensure that FDA's standards for the minimum quality of bottled water, as affected by DEHP, will be no less protective of the public health than those set by the Environmental Protection Agency (EPA) for public drinking water.

We, the U.S. Fish and Wildlife Service (Service), propose to revise critical habitat for the tidewater goby (Eucyclogobius newberryi) under the Endangered Species Act of 1973, as amended (Act). In total, approximately 12,157 acres (4,920 hectares) are being proposed for designation as critical habitat. The proposed revised critical habitat is located in Del Norte, Humboldt, Mendocino, Sonoma, Marin, San Mateo, Santa Cruz, Monterey, San Luis Obispo, Santa Barbara, Ventura, Los Angeles, Orange, and San Diego Counties, California.

We are superseding an existing airworthiness directive (AD) that applies to certain Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model C4-605R Variant F airplanes (collectively called A300-600 series airplanes). This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

We are superseding an existing airworthiness directive (AD) that applies to the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

We are superseding an existing airworthiness directive (AD) that applies to the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: