November 2008 – Federal Register Recent Federal Regulation Documents

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.

The Food and Drug Administration (FDA) is announcing the availability of proposed and final documents that have been prepared by Study Group 1 of the Global Harmonization Task Force (GHTF). These documents represent a harmonized proposal and recommendation from the GHTF Study Group that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacture of products in the United States.

The Nuclear Regulatory Commission (NRC) is making available preliminary draft proposed rule language to amend its regulations to add a new part 37 to Title 10 of the Code of Federal Regulations. This new Part 37 will contain the security (physical protection) requirements that are designed to provide reasonable assurance of preventing the theft or diversion of Category 1 and Category 2 quantities of radioactive material as designated by the International Atomic Energy Agency (IAEA). The new provisions will address background checks, fingerprinting, access control, physical security during use, and physical security during any transport of category 1 and category 2 quantities of material. At this time, the staff is only posting the preliminary draft language for the physical protection of the material while it is being transported. These requirements will be contained in subpart D of the new part 37. Draft preliminary language for other aspects of the proposed new part 37 will be posted and noticed in the future. The availability of the preliminary draft rule language is intended to inform stakeholders of the current status of the NRC's activities and solicit public comments on the information at this time. Comments may be provided as indicated under the ADDRESSES heading. The NRC may post updates periodically under Docket NRC-2008-0120 on the Federal eRulemaking Portal at https://www.regulations.gov that may be of interest to stakeholders.

This notice announces a meeting to hold a demonstration of the allocation method that the Federal Aviation Administration will use to allocate limited slots for its congestion management rules for John F. Kennedy International Airport, Newark Liberty International Airport, and LaGuardia Airport (Final Congestion Rules). [Docket No. FAA-2008- 0517, Notice No. 08-05 and Docket No. FAA-2006-25709, Notice No. 93- 87].

The FAA is amending the regulations governing the packing interval for certain types of parachutes. Currently, the FAA prohibits most parachutes from being used or carried aboard an aircraft and available for emergency use unless they have been packed within the previous 120 days. New reliability data from the parachute industry and other sources indicate that the packing interval should be increased; therefore, we are lengthening the interval from 120 to 180 days. This final rule revises the parachute packing interval and ensures safe use.

This document contains a minor correction to the final rulemaking that the Department of Veterans Affairs (VA) published at 73 FR 54693 on September 23, 2008. The rulemaking relates to a revision of the portion of VA's Schedule for Rating Disabilities that addresses neurological conditions and convulsive disorders to provide detailed and updated criteria for evaluating residuals of traumatic brain injury (TBI).

In accordance with section 102(2)(c) of the National Environmental Policy Act of 1969 and 43 CFR Part 3809, the Bureau of Land Management (BLM) Elko Field Office has prepared with the assistance of a third party contractor, a Draft Environmental Impact Statement (DEIS) on Newmont Mining Corporation's proposed Emigrant Project Plan of Operations. The project area is located in Elko County about ten miles south of Carlin, Nevada. The DEIS analyzes potential environmental impacts that could result from the open pit mine project during the projected 10-year operating period. This is the second DEIS issued for this project. The original DEIS was issued March 25, 2005.

Notice is hereby given, in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770, 5 U.S.C. App 1, section 10), of the tenth, eleventh, and twelfth meetings of the Negotiated Rulemaking Advisory Committee for Off-Road Vehicle Management at Cape Hatteras National Seashore. (See DATES section.)

We, the Fish and Wildlife Service, published a notice requesting public comments on a right-of-way (ROW) permit application we received from Texas Gas Transmission, LLC (Texas Gas), to install a natural gas pipeline under lands within Hillside National Wildlife Refuge (NWR) in Holmes County, MS. The company chose an alternate route that bypasses Hillside NWR and no longer seeks a ROW permit from us, and has withdrawn its application. Therefore, we are not seeking comments on the application.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the new information collection, 4-Rivers Application and Drawing.

The U.S. Army Corps of Engineers, New Orleans District, Regulatory Branch has received a request for Department of the Army authorization from the Louisiana Department of Transportation and Development to construct a modern, high-speed, 4-lane arterial highway from the southern terminus of the current modern 4-lane arterial portion of LA 21 in Bush, LA to I-12 in St. Tammany Parish, a distance of between 17.4 and 21 miles. The project proposes work in wetlands and structural crossings of various waterways in the project area. The EIS will be used to ensure compliance with the National Environmental Policy Act (NEPA), to determine the least damaging, yet practicable alternative and as a basis for the permit decision.

The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designation for epinephrine used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs as of December 31, 2011. Epinephrine MDIs containing an ODS cannot be marketed after this date.

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), announcement is made of the following committee meeting: Name of Committee: Board of Visitors, Defense Language Institute Foreign Language Center, Subcommittee of the Army Education Advisory Committee. Date: December 17-18, 2008. Place of Meeting: December 17: Defense Language Institute Foreign Language Center (Monterey I Conference Room, Department of Defense Center, 400 Gigling Road, Seaside, CA 93955). December 18: Defense Language Institute Foreign Language Center (Weckerling Center, Presidio of Monterey, Monterey, CA 93944). Time of Meeting: Approximately 8 a.m. through 4:45 p.m. Board Mission: The DLIFLC Board of Visitors (BoV) is governed by the Federal Advisory Committee Act (FACA) of 1972, as amended, and is a subcommittee of the Army Education Advisory Committee (AEAC). The purpose of the DLIFLC BoV is to provide the Commandant, through the Army Education Advisory Committee, with advice on matters related to the Institute's mission, specifically: academic policies, staff and faculty development, student success indicators, curricula, educational methodology and objectives, program effectiveness, instructional methods, research, and academic administration. Board Membership: The Board is composed of 10 members.