August 25, 2005 – Federal Register Recent Federal Regulation Documents

On December 2, 2004, the proposed List of Fisheries (LOF) for 2005 under the Marine Mammal Protection Act (MMPA) was published in the Federal Register. NMFS subsequently prepared a draft Environmental Assessment (EA) on the process for classifying U.S. commercial fisheries on the LOF. NMFS is reopening the comment period on the proposed 2005 LOF for an additional 60 days to allow the public to concurrently review and comment on both the draft EA and proposed 2005 LOF.

This action establishes a Class E airspace area at Marana Regional Airport, AZ. The establishment of an Area Navigation (RNAV) Global Positioning System (GPS) Instrument Approach Procedures (IAP) RNAV (GPS) Runway (RWY) 3, 12, 21 and 30 IAP and a Nondirectional Radio Beacon (NDB) IAP to RWY 12 at Marana Regional Airport, Tucson, AZ has made this action necessary. Additional controlled airspace extending upward from 700 feet or more above the surface of the earth is needed to contain aircraft executing these RNAV (GPS) and NDB approach procedures. The intended effect of this action is to provide adequate controlled airspace for Instrument Flight Rules operations at Marana Regional Airport, Tucson, AZ.

This action establishes the Class E airspace area at Dona Ana County, Santa Teresa, NM (K5T6) to provide adequate controlled airspace for the area navigation (RNAV) global positioning system (GPS) standard instrument approach procedure (SIAP).

The Food and Drug Administration (FDA) is classifying ribonucleic acid (RNA) preanalytical systems 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: RNA Preanalytical Systems (RNA Collection, Stabilization, and Purification Systems for RT-PCR Used in Molecular Diagnostic Testing).'' 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 announcing the availability of a guidance document that will serve as the special control for the device.

This proposed rule revises regulations governing the inspection and certification for fresh fruits, vegetables and other products by increasing by approximately 15 percent certain fees charged for the inspection of these products at destination markets. These revisions are necessary in order to recover, as nearly as practicable, the costs of performing inspection services at destination markets.

MMS is changing some existing fees and implementing several new fees to offset MMS's costs of performing certain services relating to its minerals programs.

This document contains proposed regulations under sections 162(k) and 404(k) of the Internal Revenue Code (Code) relating to employee stock ownership plans (ESOPs). The regulations provide guidance concerning which corporation is entitled to the deduction for applicable dividends under section 404(k). These regulations also clarify that a payment in redemption of employer securities held by an ESOP is not deductible. These regulations will affect administrators of, employers maintaining, participants in, and beneficiaries of ESOPs. In addition, they will affect corporations that make distributions in redemption of stock held in an ESOP.

On April 12, 2003, the EPA issued national emission standards for hazardous air pollutants (NESHAP) for reinforced plastics composites production, which were issued under section 112 of the Clean Air Act (CAA). This action will amend the final rule to revise compliance options for open molding, correct errors, and add clarifications to sections of the rule that were not clear. In the Rules and Regulations section of this Federal Register, we are taking direct final action on the proposed amendments because we view the amendments as noncontroversial and anticipate no adverse comments. We have explained our reasons for the amendments in the direct final rule. If we receive no adverse comments, we will take no further action on the proposed amendments. If we receive adverse comments, we will withdraw only those provisions on which we received adverse comments. We will publish a timely withdrawal in the Federal Register indicating which provisions will become effective and which provisions are being withdrawn. If part or all of the direct final rule in the Rules and Regulations section of today's Federal Register is withdrawn, all comments pertaining to those provisions will be addressed in a subsequent final rule based on the proposed amendments. We will not institute a second comment period on the subsequent final action. Any parties interested in commenting must do so at this time.

This document contains final regulations under section 951(a) of the Internal Revenue Code (Code) that provide guidance for determining a United States shareholder's pro rata share of a controlled foreign corporation's (CFC's) subpart F income, previously excluded subpart F income withdrawn from investment in less developed countries, and previously excluded subpart F income withdrawn from foreign base company shipping operations.

The Food and Drug Administration (FDA) is amending its combination product regulations to define ``mode of action'' (MOA) and ``primary mode of action'' (PMOA). Along with these definitions, the final rule sets forth an algorithm the agency will use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product. Finally, the final rule will require a sponsor to base its recommendation of the agency component with primary jurisdiction for regulatory oversight of its combination product by using the PMOA definition and, if appropriate, the assignment algorithm. The final rule is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms.