September 20, 2005 – Federal Register Recent Federal Regulation Documents

Base (1% annual chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

This interim rule lists communities where modification of the Base (1% annual chance) Flood Elevations (BFEs) is appropriate because of new scientific or technical data. New flood insurance premium rates will be calculated from the modified BFEs for new buildings and their contents.

EPA is proposing to approve revisions to the Wisconsin State Implementation Plan (SIP) submitted by the State of Wisconsin on July 28, 2005. These revisions include General and Registration permit programs that provide for the issuance of general and registration permits as part of the State's construction permit and operation permit programs. In addition, these permit programs may include the regulation of hazardous air pollutants (HAPs) which may be regulated under section 112 of the Clean Air Act (the Act). Thus, EPA is also proposing approval of Wisconsin's general and registration permit program under section 112(l) of the Act. These SIP revisions also contain changes to definitions related to Wisconsin's air permit program, as well as a minor technical change to provide correct references to the recently updated chapter NR 445, which was inadvertently omitted in the processing of that rule package. Additionally, these revisions clarify an existing construction permit exemption and operation permit exemption for certain grain storage and drying operations. This clarification is necessary to ensure that column dryers and rack dryers are included in the exemption criteria.

The Nuclear Regulatory Commission (NRC) is amending its regulations revising the Transnuclear, Inc., Standardized NUHOMS[supreg] System listing within the ``List of approved spent fuel storage casks'' to include Amendment No. 8 to Certificate of Compliance Number (CoC No.) 1004. Amendment No. 8 to the Standardized NUHOMS[supreg] System CoC will add a new spent fuel storage and transfer system, designated the NUHOMS[supreg]-24PTH System, and modify the NUHOMS[supreg]-32PT and -24PHB dry shielded canister designs.

The Food and Drug Administration (FDA) is classifying the oral rinse to reduce the adhesion of dental plaque device into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

The Food and Drug Administration (FDA) is issuing proposed regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drug products. The regulations are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. We are proposing to establish CGMP requirements for approved PET drug products. For investigational and research PET drugs, the proposed rule states that the requirement to follow CGMP may be met by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are proposing to establish these CGMP requirements for all PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance entitled ``PET Drug Products Current Good Manufacturing Practice (CGMP).''