April 2009 – Federal Register Recent Federal Regulation Documents

The State of Montana has applied to EPA for final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant final authorization to the hazardous waste program changes submitted by the State of Montana. In the ``Rules and Regulations'' section of this Federal Register, EPA is authorizing the changes in an immediate final rule. EPA did not propose the rule prior to issuing the immediate final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this authorization in the preamble to the immediate final rule. Unless we get written comments that oppose this authorization during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. If we receive comments that oppose this action, we will publish a document in the Federal Register

The Coast Guard is establishing a temporary safety zone on the navigable waters of the San Diego Bay in support of the Red Bull Air Races. The safety zone is necessary to provide for the safety of the crew, spectators, participants and other vessels and users of the waterway. Persons and vessels will be prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized to do so by the Captain of the Port or his designated representative.

In compliance with the Paperwork Reduction Act of 1995, this request for comments announces that the U.S. Coast Guard is forwarding three Information Collection Requests (ICRs), abstracted below, to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB) requesting an extension of its approval for the following collections of information: (1) 1625-0101, Periodic Gauging and Engineering Analyses for Certain Tank Vessels Over 30 Years Old; (2) 1625-0102, National Response Resource Inventory; and (3) 1625- 0103, Mandatory Ship Reporting System for the Northeast and Southeast Coasts of the United States. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.

The FAA is issuing this notice to advise the public of a meeting of RTCA Government/Industry Air Traffic Management Advisory Committee.

This action proposes to amend Class E airspace at Ankeny, IA. Cancellation of NDB approaches at Ankeny Regional Airport has made it necessary to reconfigure Class E airspace. Controlled airspace is necessary to accommodate Standard Instrument Approach Procedures (SIAPs) at Ankeny Regional Airport, Ankeny, IA. This action also would update the geographic coordinates of the airport to coincide with the FAA's National Aeronautical Charting Office. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) aircraft operations at Ankeny Regional Airport.

This action proposes special conditions for the Boeing Model 747-8/-8F airplane. This airplane will have novel or unusual design features associated with a four-post main landing gear system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Merial Ltd. to Cross Vetpharm Group Ltd.

The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 216: Aeronautical Systems Security.

The FAA is issuing this notice to advise the public of a meeting of the NextGen Mid-Term Implementation Task Force.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (185) entitled ``Target Animal Safety for Veterinary Pharmaceutical Products,'' VICH GL43. The purpose of this harmonized guidance is to provide recommendations regarding target animal safety (TAS) evaluation for regulatory submission of an Investigational Veterinary Pharmaceutical Product (IVPP), which is appropriate for determining the safety of an IVPP in the target animal. The guidance includes recommendations on including identification of target organs, where possible, and confirmation of margin of safety, using the minimum number of animals appropriate for the studies.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.'' The draft guidance document provides technical and scientific information for sponsors to consider in developing information to support a marketing application for a pen, jet, or related injector device intended for use with drugs or biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone. For a combination product that includes the injector, the marketing application would typically be a new drug application (NDA) or a biological licensing application (BLA).

Following the Senate Appropriations Committee's recommendation, the Health Resources and Services Administration (HRSA) will give funding preference during the FY 2009 competition to current and former Healthy Start grantees with expiring or recently expired project periods.

This notice advises interested persons that the Pension Benefit Guaranty Corporation (``PBGC'') has received a request from the Freight Drivers and Helpers Local Union No. 557 Pension Fund for a determination of substantial damage under section 4203(d)(4) of the Employee Retirement Income Security Act, as amended (``ERISA''), with respect to the cessation of covered operations under the plan by USF Red Star, Inc. Section 4203(d) provides a special withdrawal rule for cessations of the obligation to contribute or the cessation of operations involving plans and employers in the trucking industry. Under that special rule, an employer ceasing covered operations is considered not to have withdrawn from the plan if certain conditions are met. One of these conditions is the employer must furnish a bond or deposit money in escrow with a bank or financial institution satisfactory to the plan. After the bond/escrow requirement has been satisfied, the PBGC may make a determination under section 4203(d)(4) that the cessation has caused substantial damage to the plan's contribution base, in which case the employer will be treated as having withdrawn from the plan and the bond/escrow will be paid to the plan. In making a determination, PBGC will consider the cessation of the obligation to contribute or cessation of covered operations by other employers. Thus, a determination in any one case may affect other cases involving the same plan. The purpose of this notice is to advise interested persons of this request for such a determination and to solicit their views on it.

This document is guidance and a request for comments under section 13402 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5). ARRA was enacted on February 17, 2009. The HITECH Act (the Act) at section 13402 requires the Department of Health and Human Services (HHS) to issue interim final regulations within 180 days of enactment to require covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and their business associates to provide for notification in the case of breaches of unsecured protected health information. For purposes of these requirements, section 13402(h) of the Act defines ``unsecured protected health information'' to mean protected health information that is not secured through the use of a technology or methodology specified by the Secretary in guidance, and requires the Secretary to issue such guidance no later than 60 days after enactment and to specify within the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals. Through this document, HHS is issuing the required guidance and seeking public comment both on the guidance as well as the breach notification provisions of the Act generally to inform the future rulemaking and updates to the guidance.

The Internal Revenue Service will host the 2009 Software Developers Conference on June 8 and 9, 2009. The conference will be held at the Marriott Crystal Gateway Hotel in Arlington, Virginia. Listed is a summary of the agenda along with planned discussion topics.

The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the name of one newly-designated individual whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, ``Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism.''

The U.S. Naval Academy Board of Visitors will meet to make such inquiry, as the Board shall deem necessary into the state of morale and discipline, the curriculum, instruction, physical equipment, fiscal affairs, and academic methods of the Naval Academy. The meeting will include discussions of personnel issues at the Naval Academy, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. The executive session of this meeting will be closed to the public.

The New England Fishery Management Council's (Council) Herring Advisory Panel will meet to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

The Office of Small and Disadvantaged Business Utilization of the Department of the Interior is hosting a Vendor Outreach Workshop for small businesses in the northwest region of the United States that are interested in doing business with the Department. The Fish and Wildlife Service, Bureau of Land Management, and U.S. Geological Survey are partnering in this exciting event that will promote small business. This outreach workshop will review market contracting opportunities for the attendees. Business owners will be able to share their individual perspectives with Contracting Officers, Program Managers and Small Business Specialists from the Department. Following the workshop, businesses will also participate in a matchmaking event that will allow businesses to talk with Department representatives during roundtable discussions.