January 17, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational ``Phase 1'' drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and- comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled ``INDs Approaches to Complying With CGMP During Phase 1'' to provide further guidance on the subject.

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend our current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational ``Phase 1'' drugs from complying with the regulatory requirements. We will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled ``INDsApproaches to Complying With CGMP During Phase 1'' to provide further guidance on the subject.

The Servicemembers Civil Relief Act, as codified at 50 U.S.C. App. Sec. 531, prohibits a landlord from evicting a Service member (or the Service member's family) from a residence during a period of military service except by court order. The law as originally passed by Congress applied to monthly rents of $2,400 or less. The law requires the Department of Defense to adjust this amount annually to reflect inflation, and to publish the new amount in the Federal Register. We have applied the inflation index required by the statute. The maximum monthly rental amount for U.S.C. App. Sec. 531(a)(1)(A)(ii) as of January 1, 2006, will be $2,615.16.

The FAA is adopting a new airworthiness directive (AD) for all Airbus Model A300 B2 and B4 series airplanes. This AD requires repetitive replacement of the angle of attack (AOA) sensors with new or overhauled AOA sensors. This AD also provides an optional terminating action for the repetitive replacements. This AD results from reports of several false stall warnings associated with stick-shaker activation, occurring during take-off. We are issuing this AD to prevent false stall warnings associated with stick-shaker activation, which could result in increased pilot workload as the pilot tries to determine the cause of the stall warning and possible reduction in the pilot's ability to control the airplane.

The FAA is adopting a new airworthiness directive (AD) for all Pacific Aerospace Corporation (PAC) Ltd. Model 750XL airplanes. This AD contains the same information as emergency AD 2005-26-53 and publishes the action in the Federal Register. This AD requires you to insert text into the Limitations Section of the Airplane Flight Manual (AFM) that reduces the maximum takeoff weight from 7,500 pounds to 7,125 pounds. This AD results from mandatory continuing airworthiness information (MCAI) issued by the airworthiness authority for New Zealand. We are issuing this AD to reduce the maximum takeoff weight that will allow wing ultimate load requirements to be met. If wing ultimate load requirements are not met, wing failure could result and subsequent loss of control of the airplane.

This document addresses adding a definition of the term ``postal service'' to the rules of practice. This change is prompted by the Postal Service's action with respect to nonpostal initiatives. There is often controversy and uncertainty regarding the postal character of the services provided under those initiatives. The definition provides guidance to the Postal Service and the general public concerning services that are subject to sections 3622 and 3623 of the Postal Reorganization Act.

Based on its review of the air quality criteria and national ambient air quality standards (NAAQS) for particulate matter (PM), EPA proposes to make revisions to the primary and secondary NAAQS for PM to provide requisite protection of public health and welfare, respectively, and to make corresponding revisions in monitoring reference methods and data handling conventions for PM. With regard to primary standards for fine particles (particles generally less than or equal to 2.5 micrometers ([mu]m) in diameter, PM2.5), EPA proposes to revise the level of the 24-hour PM2.5 standard to 35 micrograms per cubic meter ([mu]g/ m3), providing increased protection against health effects associated with short-term exposure (including premature mortality and increased hospital admissions and emergency room visits) and to retain the level of the annual PM2.5 standard at 15 [mu]g/ m3, continuing protection against health effects associated with long-term exposure (including premature mortality and development of chronic respiratory disease). The EPA solicits comment on alternative levels of the 24-hour PM2.5 standard (down to 25 [mu]g/m3 and up to 65 [mu]g/m3) and the annual PM2.5 standard (down to 12 [mu]g/m3), and on alternative approaches for selecting the standard levels. With regard to primary standards for particles generally less than or equal to 10 [mu]m in diameter (PM10), EPA proposes to revise the 24-hour PM10 standard in part by establishing a new indicator for thoracic coarse particles (particles generally between 2.5 and 10 [mu]m in diameter, PM10-2.5), qualified so as to include any ambient mix of PM10-2.5 that is dominated by resuspended dust from high-density traffic on paved roads and PM generated by industrial sources and construction sources, and excludes any ambient mix of PM10-2.5 that is dominated by rural windblown dust and soils and PM generated by agricultural and mining sources. The EPA proposes to set the new PM10-2.5 standard at a level of 70 [mu]g/m3, continuing to provide a generally equivalent level of protection against health effects associated with short-term exposure (including hospital admissions for cardiopulmonary diseases, increased respiratory symptoms and possibly premature mortality). Also, EPA proposes to revoke, upon finalization of a primary 24-hour standard for PM10-2.5, the current 24- hour PM10 standard in all areas of the country except in areas where there is at least one monitor located in an urbanized area (as defined by the U.S. Bureau of the Census) with a minimum population of 100,000 that violates the current 24-hour PM10 standard based on the most recent three years of data. In addition, EPA proposes to revoke the current annual PM10 standard upon promulgation of this rule. The EPA solicits comment on alternative approaches for selecting the level of a 24-hour PM10-2.5 standard, on alternative approaches based on retaining the current 24-hour PM10 standard, and on revoking and not replacing the 24-hour PM10 standard. With regard to secondary PM standards, EPA proposes to revise the current standards by making them identical to the suite of proposed primary standards for fine and coarse particles, providing protection against PM-related public welfare effects including visibility impairment, effects on vegetation and ecosystems, and materials damage and soiling. Also, EPA solicits comment on adding a new sub-daily PM2.5 standard to address visibility impairment.