December 17, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1).'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides recommendations on nonclinical studies to support the safety of clinical trials and marketing applications for biotechnology-derived pharmaceuticals. The draft guidance is intended to clarify and provide greater detail to the nonclinical recommendations in the ICH guidance entitled ``S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals'' (ICH S6) published in the Federal Register of November 18, 1997 (62 FR 61515).

We propose to supersede Airworthiness Directive (AD) 2009-09- 09, which applies to certain Cessna Aircraft Company (Cessna) (type certificate previously held by Columbia Aircraft Manufacturing (previously The Lancair Company)) Models LC40-550FG, LC41-550FG, and LC42-550FG airplanes. AD 2009-09-09 currently requires repetitive inspections of the rudder hinges and the rudder hinge brackets for damage, i.e., cracking, deformation, and discoloration. If damage is found during any inspection, AD 2009-09-09 also requires replacing the damaged rudder hinge and/or rudder hinge bracket. Since we issued AD 2009-09-09, Cessna has developed a modification that, when incorporated, would terminate the repetitive inspections required by AD 2009-09-09. The FAA has determined that long-term continued operational safety will be better assured by design changes that removed the source of the problem, rather than by repetitive inspections or other special procedures. Consequently, this proposed AD would retain the inspection requirements of AD 2009-09-09 and add a terminating action for the inspection requirements. We are proposing this AD to detect and correct damage in the rudder hinges and the rudder hinge brackets, which could result in failure of the rudder. This failure could lead to loss of control.

Bureau of Land Management, Colorado State Office, Lakewood, Colorado, hereby gives notice that a public hearing will be held to receive comments on the environmental assessment, geologic engineering report, and maximum economic recovery of Federal coal to be offered. An application for coal lease was filed by New Elk Coal Company, LLC, requesting the Bureau of Land Management offer for competitive lease 1,279.62 acres of Federal coal in Las Animas County, Colorado.

This document contains corrections to final regulations (TD 9443) that were published in the Federal Register on Thursday, January 15, 2009 (74 FR 2370) relating to postponement of certain tax-related deadlines either due to service in a combat zone or due to a Federally declared disaster. The regulations reflect changes in the law made by the Victims of Terrorism Tax Relief Act of 2001, the Tax Extenders and Alternative Minimum Tax Relief Act of 2008 (TEAMTRA), and current IRS practice.

We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to expand the listing of the Canada lynx (Lynx canadensis) to include the State of New Mexico, under the Endangered Species Act of 1973, as amended (Act). After a review of the best available scientific and commercial information, we find that the petition to change the boundary of the listing of Canada lynx is warranted but precluded by higher priority actions to amend the Lists of Endangered and Threatened Wildlife and Plants. We have determined that Canada lynx are regularly and frequently crossing the State boundary between Colorado and New Mexico. When lynx cross the boundary, their status under the Act changes, leaving lynx in New Mexico without Federal protection. Upon publication of this 12-month petition finding, we will add lynx in New Mexico to our candidate species list with a listing priority number of 12. We will develop a proposed rule to amend the listing of lynx in the lower 48 States as our priorities allow (see section of Preclusion and Expeditious Progress).

This document proposes to amend U.S. Customs and Border Protection (CBP) regulations by removing the provisions pertaining to the Land Border Carrier Initiative Program (LBCIP). The LBCIP is a voluntary industry partnership program under which participating land and rail commercial carriers agree to enhance the security of their facilities and conveyances to prevent controlled substances from being smuggled into the United States.

The following public hearing on proposed amendments to the Federal Rules of Evidence, has been canceled: Evidence Rules Hearing, January 5, 2010, in Phoenix, AZ.

EPA is taking direct final action to approve a revision to the Monterey Bay Area portion of the California State Implementation Plan. Submitted by the California Air Resources Board on December 19, 2007, this plan revision consists of a maintenance plan prepared for the purpose of providing for continued attainment of the 8-hour ozone standard in Monterey Bay through the year 2014 and thereby satisfying the related requirements under Section 110(a)(1) of the Clean Air Act and EPA's phase 1 rule implementing the 8-hour ozone national ambient air quality standard. EPA is taking this action pursuant to those provisions of the Clean Air Act that obligate the Agency to take action on submittals of state implementation plans and plan revisions.

This document contains proposed regulations relating to reporting sales of securities by brokers and determining the basis of securities. The proposed regulations reflect changes in the law made by the Energy Improvement and Extension Act of 2008 that require brokers when reporting the sale of securities to the IRS to include the customer's adjusted basis in the sold securities and to classify any gain or loss as long-term or short-term. This document also contains proposed regulations reflecting changes in the law that alter how taxpayers compute basis when averaging the basis of shares acquired at different prices and that expand the ability of taxpayers to compute basis by averaging. The document also proposes regulations that provide brokers and others until February 15 to furnish certain information statements to customers. This document also contains proposed regulations that implement new reporting requirements imposed upon persons that transfer custody of stock and upon issuers of stock regarding organizational actions that affect the basis of the issued stock. This document also contains proposed regulations reflecting changes in the law that alter how brokers report short sales of securities. Finally, this document provides for a notice of a public hearing on these proposed regulations.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec. 104(i)(3) [42 U.S.C. 9604(i)(3)], directs the ATSDR Administrator to prepare toxicological profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile. This notice announces the availability of the 23rd set of toxicological profiles, which consists of three new and two updated drafts prepared by ATSDR for review and comment.