July 22, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.'' This guidance provides a description and basis for a process by which to select a maximum recommended starting dose (MRSD) for a first-in-human clinical trial of a therapeutic in adult healthy volunteers.

In accordance with the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended, the National Aeronautics and Space Administration announce a forthcoming meeting of the NASA Advisory Council (NAC), Financial Audit Committee (NFAC).

NMFS is prohibiting directed fishing for Pacific Ocean perch in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2005 total allowable catch (TAC) of Pacific Ocean perch in the Western Regulatory Area of the GOA.

In accordance with Section 102 of the National Environmental Policy Act (NEPA), the Bureau of Land Management (BLM) announces the availability of a Final Environmental Impact Statement (EIS) that evaluates, analyzes, and discloses to the public direct, indirect, and cumulative environmental impacts of a proposed integrated pest management program at the Horning Seed Orchard in Clackamas County, Oregon, in BLM's Salem District. The integrated pest management program is proposed to control the insect, weed, animal, and disease problems at the orchard, and to maintain healthy, vigorous crop trees for the production of seed and other vegetative materials used for reforestation and a variety of land management actions.

In accordance with Section 102 of the National Environmental Policy Act (NEPA), the Bureau of Land Management (BLM) announces the availability of a Final EIS that evaluates, analyzes, and discloses to the public direct, indirect, and cumulative environmental impacts of a proposed integrated pest management program at the Provolt and Sprague Seed Orchards in Jackson and Josephine Counties, Oregon, in BLM's Medford District. The integrated pest management program is proposed to control the insect, weed, animal, and disease problems at the orchards, and to maintain healthy, vigorous crop trees for the production of seed and other vegetative materials used for reforestation and a variety of land management actions.

This announces the availability of the FSEIS that assesses the potential environmental impacts of the construction and operation of a range of treatment and disposal alternatives for the SBIWTP to achieve compliance with the CWA and the requirements contained in its National Pollutant Discharge Elimination System (NPDES) permit. Situated in the United States at the United States/Mexico border, the SBIWTP treats sewage flows originating from the City of Tijuana, Mexico and the surrounding region and discharges the treated effluent into the Pacific Ocean through an ocean outfall. In December 2004, the USIBWC published a Draft SEIS (DSEIS) for this action which considered existing and new alternatives that would enable the USIBWC to bring the SBIWTP into compliance with the CWA and the requirements contained in its NPDES permit and to evaluate new information on the current discharges of advanced primary effluent from the SBIWTP through the South Bay Ocean Outfall (SBOO), as well as potential interim actions that would continue operations of the SBIWTP until the SBIWTP achieves CWA compliance. The United States Environmental Protection Agency (USEPA), Region 9, San Francisco, California, is a Cooperating Agency for this action.

The Securities and Exchange Commission (``Commission'') is adopting amendments to its rules and Form 25 to streamline the procedures for removing from listing, and withdrawing from registration, securities under Section 12(b) of the Securities Exchange Act of 1934 (``Exchange Act''). The final rules require all issuers and national securities exchanges seeking to delist and/or deregister a security in accordance with the rules of an exchange and the Commission to file the amended Form 25 in an electronic format with the Commission on the EDGAR database. The final rules also provide that the Form 25 serves as an exchange's notice to the Commission under Section 19(d) of the Exchange Act. Finally, the final rules exempt, on a permanent basis, standardized options and security futures products traded on a national securities exchange from Section 12(d) of the Exchange Act. The amendments serve to reduce regulatory burdens on the exchanges and issuers, and to make the delisting and deregistration process more transparent and efficient in the interest of investors and the public.

This notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.

The FAA is adopting a new airworthiness directive (AD) for certain Airbus Model A300-600 series airplanes. This AD requires an inspection for evidence of chafing between the hydraulic flexible hose and the ram air turbine (RAT) hub, and related investigative and corrective actions if necessary. This AD is prompted by reports of holes in the RAT hub cover. We are issuing this AD to prevent a hole in the RAT hub cover. A hole in the RAT hub cover could allow water to enter the RAT governing mechanism, freeze during flight, and jam the governing mechanism. In addition, the metal particles that result from chafing between the hydraulic flexible hose and the RAT could mix with the lubricant grease and degrade the governing mechanism. In an emergency, a jammed or degraded RAT could result in its failure to deploy, loss of hydraulic pressure or electrical power to the airplane, and consequent reduced controllability of the airplane.

This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will be meeting to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary of the Department of Health and Human Services (the Secretary). This meeting is open to the public. In addition, this notice invites all organizations representing physicians to submit nominations for consideration to fill four seats that will be vacated by current Council members in 2006.

This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting concerns the treatments for bone fractures that fail to progress to union. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

This amendment adopts a new airworthiness directive (AD), applicable to all Lockheed Model L-1011-385 series airplanes, that requires repetitive inspections to detect corrosion or fatigue cracking of certain structural elements of the airplane; corrective actions if necessary; and incorporation of certain structural modifications. This action is necessary to prevent corrosion or fatigue cracking of certain structural elements, which could result in reduced structural integrity of the airplane. This action is intended to address the identified unsafe condition.

The Central Intelligence Agency has undertaken and completed an Agency-wide review of its Privacy Act systems of records. As a result of this review, in the May 24 2005 issue of the Federal Register, the Agency solicited public comments on the complete set of proposed revised Privacy Act systems of records notices, the proposed modification of one of its existing routine uses, and the proposed addition of seven new routine uses to its ``Statement of General Routine Uses'' for information subject to the Privacy Act. As required by the Privacy Act, the Agency provided an opportunity for interested persons to submit comments on these notices and routine uses. The Agency did not receive any comments.