April 13, 2011 – Federal Register Recent Federal Regulation Documents

On October 12, 2010, the President signed the Combat Methamphetamine Enhancement Act of 2010 (MEA). It establishes new requirements for mail-order distributors of scheduled listed chemical products. Mail-order distributors must now self-certify to DEA in order to sell scheduled listed chemical products at retail. Sales at retail are those sales intended for personal use; mail-order distributors that sell scheduled listed chemical products not intended for personal use, e.g., sale to a university, are not affected by the new law. This self- certification must include a statement that the mail-order distributor understands each of the requirements that apply under part 1314 and agrees to comply with these requirements. Additionally, mail-order distributors are now required to train their employees prior to self certification. DEA is promulgating this rule to incorporate the statutory provisions and make its regulations consistent with the new requirements and other existing regulations related to self-certification.

Pursuant to our authority under the Clean Air Act (CAA or Act), EPA is proposing to disapprove the portion of the Texas CAA section 110(a)(2) ``Infrastructure'' State Implementation Plan (SIP) submittal addressing significant contribution to nonattainment or interference with maintenance in another state with respect to the 2006 24-hour fine particle (PM2.5) national ambient air quality standards (NAAQS). On November 23, 2009, the State of Texas, through the Texas Commission on Environmental Quality (TCEQ), submitted a SIP to EPA intended to address the requirements of CAA section 110(a)(2) for ``infrastructure.'' In this action, EPA is proposing to disapprove the portion of the Texas' SIP revision submittal that intended to address the section 110(a)(2)(D)(i)(I) requirements prohibiting a state's emissions from significantly contributing to nonattainment or interfering with maintenance of the NAAQS in any other state. The rationale for the disapproval action of the SIP revision is described in this proposal. This action is being taken under section 110 of the CAA.

The Securities and Exchange Commission (``Commission'') is amending Rule 19b-4(a) under the Securities Exchange Act of 1934 (the ``Exchange Act'') so that references to ``business day'' in Section 19(b) of the Exchange Act and Rule 19b-4 thereunder refer to a day other than a Saturday, Sunday, Federal holiday, a day that the U.S. Office of Personnel Management (``OPM'') has announced that Federal agencies in the Washington, DC area are closed to the public, a day on which the Commission is subject to a Federal government shutdown in the event of a lapse in appropriations, or a day on which the Commission's Washington, DC office is otherwise not open for regular business.

The Food and Drug Administration (FDA) is amending the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve exceptions or alternatives to the regulation for constituent materials. A request for an exception or alternative will be considered for approval when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions of use, including indication and patient population, for which the applicant is seeking approval. FDA is taking this action due to advances in developing and manufacturing safe, pure, and potent biological products licensed under the Public Health Service Act (the PHS Act) that, in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive. This rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.

The Coast Guard is establishing a temporary safety zone in the Buffalo Outer Harbor, Buffalo, NY for the Boom Days Fireworks. This zone is intended to restrict vessels from Doug's Dive, the NFTA small boat harbor and a portion of the Buffalo Outer Harbor, Buffalo, NY during the Boom Days Fireworks on April 16, 2011. This temporary safety zone is necessary to protect spectators and vessels from the hazards associated with a firework display.

The U.S. Environmental Protection Agency (EPA) Region 5 is publishing a direct final Notice of Deletion of the Spiegelberg Landfill Superfund Site (Site), located in Green Oak Township, Michigan from the National Priorities List (NPL). The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix to the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). This direct final deletion is being published by EPA with the concurrence of the State of Michigan through the Michigan Department of Environmental Quality (MDEQ), because EPA has determined that all appropriate response actions under CERCLA have been completed. However, this deletion does not preclude future actions under Superfund.

This interim rule lists communities where modification of the Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because of new scientific or technical data. New flood insurance premium rates will be calculated from the modified BFEs for new buildings and their contents.

Modified Base (1% annual-chance) Flood Elevations (BFEs) are finalized for the communities listed below. These modified BFEs will be used to calculate flood insurance premium rates for new buildings and their contents.

The FAA published a proposed rule on February 1, 2011, to establish minimum standards for training of personnel who access the airport non-movement area (ramp and apron) to help prevent accidents and incidents in that area. This proposal would require a certificate holder to conduct pavement surface evaluations to ensure reliability of runway surfaces in wet weather conditions. This proposed action would also require a Surface Movement Guidance Control System (SMGCS) plan if the certificate holder conducts low visibility operations, facilitating the safe movement of aircraft and vehicles in low visibility conditions. Finally, this proposal would clarify the applicability of part 139 and explicitly prohibit fraudulent or intentionally false statements in a certificate application or record required to be maintained. This action reopens the comment period.

The Coast Guard is proposing to establish a temporary special local regulation in Boston Harbor, Boston, Massachusetts, within the Captain of the Port (COTP) Boston Zone. This special local regulation is necessary to provide for the safety of life on navigable waters during the Extreme Sailing Series Boston regatta. The special local regulation will temporarily restrict vessel traffic in a portion of Boston Harbor, and prohibit vessels not participating in the Extreme Sailing Series event from entering the designated race area.

We, the U.S. Fish and Wildlife Service, announce a 90-day finding on a petition to list the Spring Mountains acastus checkerspot butterfly (Chlosyne acastus robusta) as endangered under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that the petition presents substantial scientific or commercial information indicating that listing the Spring Mountains acastus checkerspot butterfly as endangered or threatened may be warranted. Therefore, with the publication of this notice, we are initiating a review of the status of the species to determine if listing the Spring Mountains acastus checkerspot butterfly as endangered or threatened is warranted. To ensure that this status review is comprehensive, we are requesting scientific and commercial data and other information regarding this subspecies. Based on the status review, we will issue a 12-month finding on the petition, which will address whether the petitioned action is warranted, as provided in section 4(b)(3)(B) of the Act.

The Food and Drug Administration (FDA) is responding to objections and is denying requests that it received for a hearing on the final rule that amended the food additive regulations to provide for the safe use of ionizing radiation for the reduction of Salmonella in fresh shell eggs. After reviewing objections to the final rule and requests for a hearing, the Agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking or modifying the amendment to the regulation.

The Food and Drug Administration (FDA) is proposing to amend the regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain test articles (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. This proposal is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.

In accordance with Executive Order 13563, ``Improving Regulation and Regulatory Review,'' the Department of Health and Human Services (HHS) seeks comment from interested parties to assist in the development of its preliminary plan to review existing regulations. The purpose of the plan is to establish a process by which HHS can determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make HHS's regulatory program more effective or less burdensome in achieving its regulatory objectives.

This document contains a rescheduled notice of public hearing on a notice of proposed rulemaking (REG-146097-09) that was published in the Federal Register on Tuesday, January 18, 2011 (76 FR 2852) and Friday, January 7, 2011 (76 FR 1105) providing guidance on the reporting requirements for interest on deposits maintained at U.S. offices of certain financial institutions and paid to nonresident alien individuals.

On October 29, 2010, the Department of Education published in the Federal Register (75 FR 66832) final regulations for improving integrity in the programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA), by amending the regulations for Institutional Eligibility Under the HEA, the Secretary's Recognition of Accrediting Agencies, the Secretary's Recognition Procedures for State Agencies, the Student Assistance General Provisions, the Federal Family Education Loan (FFEL) Program, the William D. Ford Federal Direct Loan Program, the Teacher Education Assistance for College and Higher Education (TEACH) Grant Program, the Federal Pell Grant Program, and the Academic Competitiveness Grant (AGC) and National Science and Mathematics Access to Retain Talent Grant (National Smart Grant) Programs. This document makes several corrections to the October 29 final regulations, including in the preamble discussion and the regulatory text.

This regulation establishes tolerances for residues of etoxazole in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

These special conditions are issued for the modification of the Eurocopter France (Eurocopter) model AS350B series, AS350D, and EC130 helicopters. These model helicopters will have novel or unusual design features when modified by installing the Hoh Aeronautics, Inc. (Hoh) complex autopilot/stabilization augmentation system (AP/SAS) that has potential failure conditions with more severe adverse consequences than those envisioned by the existing applicable airworthiness regulations. These special conditions contain the added safety standards the Administrator considers necessary to ensure the failures and their effects are sufficiently analyzed and contained.

We are adopting a new 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:

We are adopting a new 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: