June 22, 2011 – Federal Register Recent Federal Regulation Documents

The Coast Guard is establishing 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.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from medical device manufacturers of insulin pumps and continuous glucose monitors. Scientific information is being solicited to inform our Comparative Effectiveness and Safety of Insulin Delivery and Glucose Monitoring Methods for Diabetes Mellitus review, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.

This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to the proposed Illinois Route 336 (IL 336) highway project, for construction of an access-controlled, four- lane expressway on new right-of-way between the proposed Macomb Bypass in McDonough County, passing through Fulton County to Interstate 474 (I-474) on the west side of Peoria in Peoria County, Illinois. Those actions grant licenses, permits and approvals for the project.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 5305A-SEP, Salary Reduction Simplified Employee Pension-Individual Retirement Accounts Contribution Agreement.

We are requesting an extension of the proposed EIS for the USDA Forest Service Rangeland Allotment Management Planning on the Fall River West Geographic Area of the Fall River Ranger District and the Oglala Geographic Area of the Pine Ridge Ranger District, Nebraska National Forest. Our initial Notice of Intent was published in Vol. 75, No. 112 Friday, June 11, 2010. The USDA, Forest Service, will prepare an environmental impact statement (EIS) analyzing the management of rangeland vegetation resources, which includes livestock grazing, on the National Forest System (NFS) lands within the Oglala Geographic Area (OGA) of the Oglala National Grassland on the Pine Ridge Ranger District and the West Geographic Area (WGA) of the Buffalo Gap National Grassland on the Fall River Ranger District of the Nebraska National Forest (Analysis Area) areas as mapped by the 2001 Nebraska National Forest Revised Land and Resource Management Plan (Forest Plan). A Notice of Intent (NOI) for this project was published June 11, 2010 (75 No. 112 FR 33239- 33241). This revised NOI is being issued to update the project schedule. There will be a record of decision (ROD) for each geographic area. Proposed management actions would be implemented beginning in the year 2013. The agency gives notice of the full environmental analysis and decision-making process that will occur on the proposal so interested and affected people may become aware of how they may participate in the process and contribute to the final decision.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design.'' The recommendations in this guidance are intended to improve the safety and effectiveness of devices and reduce use error. This draft guidance is not final; nor is it in effect at this time.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8453-F, U.S. Estate of Trust Income Tax Declaration and Signature for Electronic and Magnetic Made Filing and Form 8879-F, IRS e-file Signature Authorization for Form 1041.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). The IRS is soliciting comments concerning information collection requirements related to methods to determine taxable income in connection with a cost sharing arrangement.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning requirements respecting the adoption or change of accounting method; extensions of time to make elections.

This document grants in full Nissan North America, Inc.'s, (Nissan) petition for exemption of the Leaf vehicle line in accordance with 49 CFR part 543, Exemption from Vehicle Theft Prevention Standard. This petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of the Theft Prevention Standard (49 CFR part 541). Nissan requested confidential treatment of specific information in its petition by letter dated February 4, 2011. The agency addressed Nissan's request for confidential treatment by letter dated April 27, 2011.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for small business entities entitled ``Topical Acne Drug Products for Over-the-Counter Human UseRevision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective.'' This guidance is intended to help small businesses understand and comply with the requirements of the final rule that adds benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products and provides new labeling requirements applicable to all OTC topical acne products marketed under the monograph (75 FR 9767, March 4, 2010) (final rule). The guidance describes the requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Fairness Act.

In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing its intention to request renewed authority for the collection of information relating to Abandoned mine reclamation funds.

We, the U.S. Fish and Wildlife Service (Service), announce that our draft comprehensive conservation plan (CCP) and environmental assessment (EA) for Bowdoin National Wildlife Refuge Complex is available. This draft CCP/EA describes how the Service intends to manage this refuge complex for the next 15 years.

In this Notice of Inquiry (NOI), the Commission seeks comment on two sets of separate, but related issues. First, we seek comment on ways in which we can facilitate the development of robust competitive markets for the provision of ancillary services from all resource types. Second, the Commission is interested in issues unique to storage devices in light of the role they can play in providing multiple services, including ancillary services. As demonstrated by recent cases that have come before the Commission, there is growing interest in rate flexibility by both purchasers and sellers of ancillary services. A variety of resources are poised to provide ancillary services but may be frustrated from doing so by certain aspects of the Commission's market-based rate policies coupled with a lack of access to the information that could help satisfy the requirements of those policies. Those with an obligation to purchase ancillary services have raised concerns with the availability of those services. In reviewing ways to foster a more robust ancillary services market, the Commission identified certain issues regarding the use of electric storage as an ancillary service resource that warranted consideration. Over time, those issues expanded into more global questions as to the role that electric storage may play in a competitive market, including how electric storage should be compensated for the full range of services it provides under the Federal Power Act, and transparency issues regarding the Commission's current accounting and reporting requirements as applied to electric storage. As such, the Commission seeks comment on: Existing restrictions on third-party provision of ancillary services, irrespective of the technologies used for such provision; and the adequacy of current accounting and reporting requirements as they pertain to the oversight of jurisdictional entities using electric storage devices.

The Plumas County Resource Advisory Committee (RAC) will hold a meeting on July 8, 2011 in Quincy, CA. The purpose of the meeting is to review applications for Cycle 11 funding and select projects to be recommended to the Plumas National Forest Supervisor for calendar year 2012 funding consideration. The funding is made available under Title II provisions of the Secure Rural Schools and Community Self- Determination Act of 2000.

This notice proposes updated regulations to enhance the integration of value engineering (VE) analysis in the planning and development of highway improvement projects. The intent of these actions is to bring the FHWA's VE regulations up-to-date and consistent with prior changes in legislation and regulations.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed 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 propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD would require replacing or modifying the upper and lower rudder power control modules (PCM). This proposed AD was prompted by a report of a rudder hard-over event on a Model 747-400 series airplane, caused by a rudder PCM manifold cracking and separating in the area of the yaw damper cavity end-cap. We are proposing this AD to prevent a failure of the lower or upper rudder PCM manifold, which could result in a hard-over of the rudder surface leading to an increase in pilot workload and a possible high-speed runway excursion upon landing.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 17, 2011, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of CSP Technologies, Inc., of Auburn, Alabama. Letters supplementing the complaint were filed on June 3 and June 7, 2011. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain flip-top vials and products using the same by reason of infringement of certain claims of U.S. Patent No. 7,537,137 (``the '137 patent''). The complaint further alleges that an industry in the United States exists or is in the process of being established as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue an exclusion order and cease and desist orders.