November 25, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Phoenix Scientific, Inc., to IVX Animal Health, Inc. In order to improve the accuracy of the regulations, erroneous entries for Phoenix Pharmaceutical, Inc., are also being removed at this time.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health. The supplemental NADA provides for revised labeling for the veterinary prescription use of injectable boldenone solution in horses.

The Food and Drug Administration (FDA) is proposing to amend its food labeling regulations for the expanded use of the nutrient content claim ``lean'' on the labels of foods categorized as ``mixed dishes not measurable with a cup'' that meet certain criteria for total fat, saturated fat, and cholesterol content. This proposal responds to a nutrient content claim petition submitted by Nestl[eacute] Prepared Foods Co. (Nestl[eacute]) under the Federal Food, Drug, and Cosmetic Act (the act). This action also is being taken to provide reliable information that would assist consumers in maintaining healthy dietary practices.

The Department of Energy (DOE) is adopting as final without change an Interim Final Rule amending the Department of Energy Acquisition Regulation (DEAR) to provide policy and procedures regarding work for non-DOE entities performed by DOE contractors who manage and operate DOE-owned or DOE-leased facilities and to make an administrative change concerning debarment and suspension officials.

EPA is proposing to approve Indiana's April 8, 2005, submittal which revises existing sulfur dioxide (SO2) emission limits for sources in Dearborn County. On April 8, 2005, Indiana submitted its final rule as published in the Indiana Register. Indiana held public hearings on the submittal on May 5, 2004 and October 6, 2004. Indiana is requesting that EPA approve the revisions to Indiana's SO2 rule for Dearborn County, which removes obsolete rule language and updates information for sources listed in the rule. These revisions will not result in an increase in SO2 emissions in Dearborn County because no emission limits were increased. In the final rules section of this Federal Register, EPA is approving the SIP revision as a direct final rule without prior proposal, because EPA views this as a noncontroversial revision and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If we do not receive any adverse comments in response to these direct final and proposed rules, we do not contemplate taking any further action in relation to this proposed rule. If EPA receives adverse comments, we will withdraw the direct final rule and will respond to all public comments in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time.

On November 24, 2004, EPA published proposed regulations to establish requirements for cooling water intake structures at Phase III facilities under section 316(b) of the Clean Water Act (CWA). EPA proposed the following three options for defining which existing facilities would be subject to uniform national requirements, based on the facility's design intake flow threshold and source waterbody type: The facility has a total design intake flow of 50 million gallons per day (MGD) or more, and withdraws from any waterbody; the facility has a total design intake flow of 200 MGD or more, and withdraws from any waterbody; or the facility has a total design intake flow of 100 MGD or more and withdraws specifically from an ocean, estuary, tidal river, or one of the Great Lakes. The proposed rule would also establish national section 316(b) requirements for new offshore oil and gas extraction facilities. This notice of data availability (NODA) summarizes significant data EPA received or collected since publication of the proposed rule and discusses how EPA may use this data in revising its analyses. EPA solicits public comment on the information presented in this notice and the record supporting this notice.

In this document, the Federal Communications Commission (Commission) examines the reach of Emergency Alert System (EAS), as currently constituted, to cover digital communications technologies that are increasingly being used by the American public to receive news and entertainmentdigital television and radio, digital cable, and satellite television and radio. The Further Notice of Proposed Rulemaking is the most recent in a series of proceedings in which the Commission has sought to contribute to an efficient and technologically current public alert and warning system.

The EPA (also, ``the Agency'' or ``we'') is amending an existing exclusion to reflect changes in ownership and name for the Vulcan Materials Company (Vulcan), Port Edwards, Wisconsin. Today's amendment documents these changes.

This final rule adopts as final, and makes amendments to, the interim final rule published on August 15, 2003. That interim final rule implemented the statutory requirement that claims for reimbursement under the Medicare Program be submitted electronically as of October 16, 2003, except where waived. These regulations identify those circumstances for which mandatory submission of electronic claims to the Medicare Program is waived.