April 8, 2009 – Federal Register Recent Federal Regulation Documents

This notice proposes special conditions for the Boeing Model 747-8/-8F airplane. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features include their effects on the structural performance. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards. Additional special conditions will be issued for other novel or unusual design features of the Boeing 747-8/-8F airplanes.

The SBA is issuing this notice to announce the location, date, time, and agenda for the next meeting of the Region II Buffalo District Advisory Council. The meeting will be open to the public.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary Cosmetic Registration Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q10 Pharmaceutical Quality System.'' 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 describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on ``Q8 Pharmaceutical Development'' and ``Q9 Quality Risk Management.''

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 4B: Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms 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 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms 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.''

NMFS is prohibiting directed fishing for Pacific ocean perch for vessels participating in the Bering Sea and Aleutian Islands (BSAI) trawl limited access fishery in the Central Aleutian District of the BSAI. This action is necessary to prevent exceeding the 2009 Pacific ocean perch total allowable catch (TAC) specified for vessels participating in the BSAI trawl limited access fishery in the Central Aleutian District of the BSAI.

This regulation establishes tolerances for the combined residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1- oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3- en-2-one), calculated as the parent compound equivalents, in or on pop corn grain and stover. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition, this regulation establishes tolerances for sweet corn, kernel, stover, and forage; and berry, lowgrowing, subgroup 13G. Interregional Research Project No. 4 (IR-4) requested these tolerances under the FFDCA. Additionally, the existing tolerance for strawberry is being deleted because it is superseded by the tolerances established for low growing berry subgroup 13-07G. Also, the tolerances for milk fat and meat byproducts of cattle, goats, horses, and sheep are being increased.In addition, this action establishes time-limited tolerances for the combined residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1- oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3- en-2-one), calculated as the parent compound equivalents, in or on soybean commodities in response to the approval of a specific exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing the use of spiromesifen on soybeans to control spider mites. The time-limited tolerances expire and are revoked on December 31, 2011.

We are adopting a new airworthiness directive (AD) for all McDonnell Douglas airplanes identified above. This AD requires revising the airplane flight manual to provide the flightcrew with procedures to preclude dry running of the fuel pumps. This AD results from fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent pump inlet friction (i.e., overheating or sparking) when the fuel pumps are continually run as the center wing fuel tank becomes empty, and/or electrical arc burnthrough, which could result in a fuel tank fire or explosion.

EPA is determining that the one-hour ozone nonattainment area in Southern New Jersey, that is, the New Jersey portion of the Philadelphia-Wilmington-Trenton, PA-NJ-DE-MD area, attained the one- hour ozone standard, is not subject to the imposition of penalty fees under section 185 of the Clean Air Act and does not need to implement contingency measures. Areas that EPA classified as severe ozone nonattainment areas for the one-hour National Ambient Air Quality Standard and did not attain the Standard by the applicable attainment date of November 15, 2005 may be subject to these penalty fees. However, since the air quality in the Philadelphia-Wilmington-Trenton area attained the ozone standard as of November 15, 2005, this area will not need to implement this fee program. This is not a redesignation of atttainment for this area, only a fulfillment of a Clean Air Act obligation to determine if an area attained the ozone standard by its applicable attainment date.

This notice announces the Agency's receipt of several initial filings of pesticide petitions proposing the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

This notice announces receipt of applications to register pesticide products containing new active ingredients not included in any currently registered products pursuant to the provisions of section 3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended.

The Executive Director of the Army's Installation Management Command has reviewed the Final Environmental Impact Statement (EElS) for Implementation of Fort Carson Grow the Army Stationing Decisions and has made the decision to proceed with all facets of the Proposed Action, with the exception that the Army has decided not to station a Combat Aviation Brigade (CAB) at Fort Carson at this time. Implementation of the Proposed Action involves the stationing of approximately 3,900 additional Soldiers at Fort Carson, the construction of new Infantry Brigade Combat Team (IBCT) facilities at the Operational Readiness Training Center site, demolition of old facilities and construction of new facilities in Fort Carson's cantonment area, and additional training at Fort Carson and the Pinon Canyon Maneuver Site (PCMS). This alternative is summarized in the Army's ROD and described fully in Chapter 2 of the FEIS.