2009 – Federal Register Recent Federal Regulation Documents

The New England Fishery Management Council's (Council) Interspecies Committee will meet to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility Test General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Sterility Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''

The FAA invites public comments about our intention to request the Office of Management and Budget's (OMB) revision of a current information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on October 16, 2009, vol. 74, no. 199, page 53311. This rule may require applicants to comply with the latest regulations in effect on the date of application for amended Type Certificates (TC) or a Supplemental TCs for aeronautical products.

In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR Part 107, Subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the applications described herein. This notice is abbreviated to expedite docketing and public notice. Because the sections affected, modes of transportation, and the nature of application have been shown in earlier Federal Register publications, they are not repeated here. Requests for modification of special permits (e.g., to provide for additional hazardous materials, packaging design changes, additional mode of transportation, etc.) are described in footnotes to the application number. Application numbers with the suffix ``M'' denote a modification request. These applications have been separated from the new application for special permits to facilitate processing.

The Pipeline and Hazardous Materials Safety Administration is proposing to amend the Hazardous Materials Regulations to incorporate provisions contained in certain widely used or longstanding special permits that have an established safety record. Special permits allow a company or individual to package or ship a hazardous material in a manner that varies from the regulations so long as an equivalent level of safety is maintained. The proposed revisions are intended to provide wider access to the regulatory flexibility offered in special permits and eliminate the need for numerous renewal requests, thus reducing paperwork burdens and facilitating commerce while maintaining an appropriate level of safety.

The following public hearing on proposed amendments to the Federal Rules of Criminal Procedure, has been canceled:

This document contains notices of pendency before the Department of Labor (the Department) of proposed exemptions from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code).

The Coast Guard is changing the regulation governing the operation of the State Route (SR) 433 Swing Span Bridge across Bonfouca Bayou, mile 7.0, at Slidell, St. Tammany Parish, Louisiana. The Louisiana Department of Transportation and Development (LDOTD) requested that the operating regulation of the SR 433 Swing Span Bridge be changed in order to allow for signaled openings to begin later in the mornings and later in the evenings during the months of daylight savings time. This change allows the bridge to open on signal, except that from 9 p.m. to 7 a.m., from March 1 through October 30, the draw shall open on signal if at least two hours' notice is given. From November 1 through February 28 or 29, the bridge will revert to the two-hour notice requirement from 6 p.m. to 6 a.m.

This notice informs the public that the Assistant Secretary- Indian Affairs proclaimed approximately 5.0 acres, more or less, to be added to the Reservation of the Pueblo of Jemez, New Mexico.

The NIEHS Superfund Research Program (SRP), in response to recommendations of the NIEHS Superfund Research Program External Advisory Panel convened in 2009, is seeking input to develop a strategic plan to provide direction to achieve its mandates described in SARA Section 311(a). Information provided will be used to develop a 5-year strategic plan to direct programmatic focus and enhance the impact of the SRP program. SRP welcomes input from sister Superfund agency representatives (i.e. United States Environmental Protection Agency, US EPA; and Agency for Toxic Substances and Disease Registry, ATSDR), other government officials, environmental health researchers, academics, members of the private sector, policy makers, the lay public, and others with an interest in the effects of hazardous substances on public health. SRP is using an online questionnaire and public meetings to receive input.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Timeframe for Submission of Tobacco Health Documents.'' This document provides written guidance to tobacco product manufacturers and importers on enforcement of the requirement to submit certain documents to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

This action proposes to modify Class E airspace at Yellowstone Airport, West Yellowstone, MT, to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedure (SIAP) at Yellowstone Airport, West Yellowstone, MT. The FAA is proposing this action to enhance the safety and management of instrument flight rules (IFR) operations at the airport.

In accordance with the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-05, approved February 17, 2009) (Recovery Act), and implementing guidance of the Office of Management and Budget (OMB), this notice advises that certain individual exceptions to the Buy American requirement of the Recovery Act have been determined applicable for work using Capital Fund Recovery Formula and Competition (CFRFC) grant funds. Specifically, exceptions were granted to the San Antonio Housing Authority in San Antonio, Texas, for the purchase and installation of a Variable Refrigerant Volume (VRV) heat recovery system for the Lewis Chatham modernization project, and to the Housing Authority of Portland, in Portland, Oregon, for the purchase of Farbo Marmoleum flooring for several modernization projects.