October 5, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ``highly similar'' (biosimilar) to, or ``interchangeable'' with, an FDA-licensed biological product. The purpose of this public hearing is to create a forum for interested stakeholders to provide input regarding the agency's implementation of the statute. FDA will take the information it obtains from the public hearing into account in its implementation of the BPCI Act.

The Department of the Army proposes to add a system of records to its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

The Department of Defense is publishing the unclassified text of three section 36(b)(1) arms sales notifications to fulfill the requirements of section 155 of Public Law 104-164, dated 21 July 1996.

The Secretary of Homeland Security determined on September 23, 2008 that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracis. On the basis of this determination, the Secretary of Health and Human Services is renewing the October 1, 2008 declaration by former Secretary Michael O. Leavitt of an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Food and Drug Commissioner under 21 U.S.C. 360bbb-3(a). This notice is being issued in accordance with section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).

The Nuclear Regulatory Commission (NRC) is amending its regulations to incorporate by reference the latest revisions of two previously incorporated regulatory guides (RGs) approving new and revised Code Cases published by the American Society of Mechanical Engineers (ASME). The RGs which are incorporated by reference are RG 1.84, ``Design, Fabrication, and Materials Code Case Acceptability, ASME Section III,'' Revision 35, and RG 1.147, ``Inservice Inspection Code Case Acceptability, ASME Section XI, Division 1,'' Revision 16. This action allows nuclear power plant licensees, and applicants for standard design certifications, standard design approvals, and manufacturing licenses under the regulations that govern license certifications, and approves the nuclear power plants to use the Code Cases listed in these RGs as alternatives to requirements in the ASME Boiler and Pressure Vessel (BPV) Code regarding the construction and inservice inspection (ISI) of nuclear power plant components. Concurrent with this action, the NRC is publishing a notice of the issuance and availability of the RGs in the Federal Register. As a result of these related actions, the Code Cases listed in these RGs are incorporated by reference into the NRC's regulations and are deemed to be legally-binding NRC requirements.

The Nuclear Regulatory Commission (NRC) is providing notice of the issuance and availability of Regulatory Guide 1.193, Rev. 3, ``ASME Code Cases Not Approved for Use.''

This amendment adopts a new airworthiness directive (AD) for Agusta Model A109E helicopters. This AD results from a mandatory continuing airworthiness information (MCAI) AD issued by the European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community. The MCAI AD states that after a report of an electrical failure, an investigation revealed inadequate functioning of the 35 amperes (Amps) battery bus (BATT BUS) circuit breaker that was not within design requirements. The actions specified in this AD are intended to replace the 35 Amps circuit breaker with a 50 Amps circuit breaker and replace the wires with oversized ones to prevent an electrical failure, loss of electrical power, and subsequent loss of control of the helicopter.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD requires incorporating changes to the electronic flight information system and the airplane flight manuals. This AD was prompted by reports of uncommanded changes to the communications radio frequency, altitude preselect, and/or transponder codes. We are issuing this AD to correct faulty integration of hardware and software, which could result in unannunciated, uncommanded changes in communications radio frequency, transponder codes, and altitude preselect settings. These uncommanded changes could result in loss of communication with air traffic control due to improper communications frequency, autopilot level off at the incorrect altitude, or air traffic control loss of proper tracking of the aircraft.

We are superseding an existing airworthiness directive (AD) for 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:

The FAA is superseding an existing airworthiness directive (AD), which applies to all Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747- 400F, and 747SR series airplanes. That AD currently requires repetitive inspections to find cracking of the web, strap, inner chords, and inner chord angle of the forward edge frame of the number 5 main entry door cutouts, and repair, if necessary. This new AD requires expanding the inspection areas to include the frame segment between stringers 16 and 23. This AD reinstates the repetitive inspections specified above for certain airplanes. This AD also requires repetitive inspections for cracking of repairs. This AD results from additional reports of cracks that have been found in the strap and inner chord of the forward edge frame of the number 5 main entry door cutouts, between stringers 16 and 23. We are issuing this AD to detect and correct such cracks. This condition, if not corrected, could cause damage to the adjacent body structure, which could result in depressurization of the airplane in flight.