July 26, 2011 – Federal Register Recent Federal Regulation Documents

We, the U.S. Fish and Wildlife Service, are initiating 5-year status reviews under the Endangered Species Act of 1973, as amended (Act), of seven animal and plant species. We conduct these reviews to ensure that our classification of each species on the Lists of Endangered and Threatened Wildlife and Plants as threatened or endangered is accurate. A 5-year review assesses the best scientific and commercial data available at the time of the review. We are requesting the public to send us any information that has become available since the most recent status reviews on each of these species. Based on review results, we will determine whether we should change the listing status of any of these species.

EPA is taking direct final action to approve revisions to the Northern Sierra Air Quality Management District (NSAQMD), Sacramento Metropolitan Air Quality Management District (SMAQMD), and South Coast Air Quality Management District (SCAQMD) portions of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from gasoline dispensing facilities, polyester resin operations, and spray booth facilities. We are approving local rules that regulate these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act).

NMFS is closing the commercial shark research fishery for non- sandbar large coastal sharks (LCS). This action is necessary because landings for the 2011 fishing season have reached at least 80 percent of the available quota.

We are amending the regulations concerning the importation of fruits and vegetables to allow the importation of fresh shepherd's purse with roots from the Republic of Korea into the United States under a combination of mitigations to reduce the risk of introducing plant pests. As a condition of entry, the shepherd's purse will have to be produced in accordance with a systems approach that will include requirements for importation of commercial consignments, pest-free place of production, removal of soil, and inspection for quarantine pests by the national plant protection organization of the Republic of Korea. The shepherd's purse will also have to be accompanied by a phytosanitary certificate with an additional declaration stating that it was grown, packed, and inspected and found to be free of pests in accordance with the regulations. This action will allow the importation of fresh shepherd's purse with roots from the Republic of Korea while continuing to protect against the introduction of plant pests into the United States.

We are adopting as a final rule, with one change, an interim rule that amended the Karnal bunt regulations to make changes to the list of areas or fields regulated because of Karnal bunt, a fungal disease of wheat. Specifically, the interim rule added portions of the Buckeye/Pretoria area of Maricopa County, AZ, to the list of regulated areas and removed Throckmorton and Young Counties, TX, portions of Riverside County, CA, and certain areas in La Paz, Maricopa, and Pinal Counties, AZ, from the list of regulated areas based on our determination that those fields or areas meet our criteria for release from regulation. The interim rule was necessary to prevent the spread of Karnal bunt to noninfected areas of the United States and to relieve restrictions on certain areas that are no longer necessary. In the interim rule, we inadvertently removed two areas in Maricopa County, AZ, from the list of regulated areas. We are returning those areas to the list in this final rule.

EPA is announcing a limited reopening of the public comment period for the proposed rule entitled ``Approval and Promulgation of Air Quality Implementation Plans; State of Tennessee; Regional Haze State Implementation Plan.'' The proposed rule was initially published in the Federal Register on June 9, 2011. Written comments on the proposed rule were to be submitted to EPA on or before July 11, 2011 (30-day comment period). On June 29, 2011, and July 1, 2011, two Commenters requested that EPA extend the comment period for the June 9, 2011, Tennessee Regional Haze proposed rulemaking for 30 to 60 days in order to review the Cross-State Air Pollution Rule (CSAPR), which replaced the Clean Air Interstate Rule on July 6, 2011. The Commenters requested the extension in order to determine any potential impacts of the CSAPR on the June 9, 2011, proposed rule. EPA is now reopening the public comment period for 15 days from the date of publication of today's action for the limited purpose of public review and comment on the potential impacts of the final CSAPR on EPA's proposed rulemaking to approve Tennessee's Regional Haze State Implementation Plan (SIP).

The Department of Homeland Security is issuing a final rule to amend its regulations to exempt portions of a newly established system of records titled, ``Department of Homeland Security/National Protection and Programs Directorate001 National Infrastructure Coordinating Center Records System of Records'' from certain provisions of the Privacy Act. Specifically, the Department exempts portions of the ``Department of Homeland Security/National Protection and Programs Directorate001 National Infrastructure Coordinating Center Records System of Records'' from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements. The Department will not claim Privacy Act exemption (k)(3) as originally published in the Notice of Proposed Rulemaking.

The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.

The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD requires revising the airplane flight manual (AFM) to advise the flightcrew to use certain procedures during descent in certain icing conditions. This AD was prompted by reports of several in-flight engine flameouts, including multiple dual engine flameout events and one total power loss event, in ice-crystal icing conditions. We are issuing this AD to ensure that the flightcrew has the proper procedures to follow in certain icing conditions. These certain icing conditions could cause a multiple engine flameout during flight with the potential inability to restart the engines, and consequent forced landing of the airplane.

The National Aeronautics and Space Administration (NASA) proposes regulations relating to requirements for the filing of claims against NASA where a potential claimant believes NASA is infringing privately owned rights in patented inventions or copyrighted works. The requirements for filing an administrative claim are important since the filing of a claim carries with it certain rights relating to the applicable statute of limitations for filing suit against the Government. The proposed regulations set forth guidelines as to what NASA considers necessary to file a claim for patent or copyright infringement, and they also provide for written notification to the claimant upon completion of an investigation by NASA.

On January 5, 2011, PHMSA published a final rule under Docket Number PHMSA-2009-0410 (HM-233B) that amended the Hazardous Materials Regulations to revise the application procedures for special permits. Specifically, the revisions required an applicant to provide additional information about its operation to enable the agency to better evaluate the applicant's ability to demonstrate an equivalent level of safety and the safety impact of operations that would be authorized in the special permit. In response to appeals submitted by entities affected by the January 5 final rule, this final rule amends requirements and provides additional clarification to the January 5 final rule.

We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the giant Palouse earthworm (Driloleirus americanus) as threatened or endangered as petitioned, and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that listing the giant Palouse earthworm is not warranted at this time. However, we ask the public to submit to us any new information that becomes available concerning the threats to the giant Palouse earthworm or its habitat at any time.

Section 101(a) of the Consumer Product Safety Improvement Act (``CPSIA'') provides that, as of August 14, 2011, children's products may not contain more than 100 parts per million (``ppm'') of lead unless the Consumer Product Safety Commission (``CPSC,'' ``Commission,'' or ``we'') determines that such a limit is not technologically feasible. The determination can only be made after notice and a hearing and after analyzing the public health protections associated with substantially reducing lead in children's products. On February 16, 2011, we conducted a public hearing to receive views from all interested parties about the technological feasibility of meeting the 100 ppm lead content limit for children's products and associated public health considerations. Through this document, we announce that children's products must meet the statutory 100 ppm lead content limit on August 14, 2011, unless otherwise excluded under CPSC regulations.\1\

The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an ``Asthma alert'') and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products.

This document advises the public of a recent decision by the Federal Aviation Administration (FAA) concerning the application of certain provisions of the regulations regarding fuel venting requirements.

The Architectural and Transportation Barriers Compliance Board is proposing accessibility guidelines for the design, construction, and alteration of pedestrian facilities in the public right-of-way. The guidelines ensure that sidewalks, pedestrian street crossings, pedestrian signals, and other facilities for pedestrian circulation and use constructed or altered in the public right-of-way by state and local governments are readily accessible to and usable by pedestrians with disabilities. When the guidelines are adopted, with or without additions and modifications, as accessibility standards in regulations issued by other federal agencies implementing the Americans with Disabilities Act, Section 504 of the Rehabilitation Act, and the Architectural Barriers Act, compliance with the accessibility standards is mandatory.