March 23, 2005 – Federal Register Recent Federal Regulation Documents

Pursuant to Section 102(2)(c) of the National Environmental Policy Act of 1969; the Council on Environmental Quality Regulations (40 CFR part 1500); and the Natural Resources Conservation Service Rules (7 CFR part 650); the Natural Resources Conservation Service, U.S. Department of Agriculture, gives notice that an environmental impact statement is not being prepared for the rehabilitation of Sandia Mountain Tributaries Site 1 (Piedra Liza Dam) in Sandoval County, New Mexico.

OMB requests comments on 2005 Draft Report to Congress on the Costs and Benefits of Federal Regulation. The full Draft Report is available at https://www.whitehouse.gov/omb/inforeg/regpolreports congress.html, and is divided into three chapters. Chapter I presents estimates of the costs and benefits of Federal regulation and paperwork, with an emphasis on the major regulations issued between October 1, 2003 and September 31, 2004. Chapter II reports the latest results of our ongoing historical examination of the trends in Federal regulatory activity and explores what we know about the validation of ex ante estimates of costs and benefits of Federal regulation by ex post studies. Chapter III includes a discussion of the implementation of the Information Quality Act.

This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2002 Jeep Liberty multipurpose passenger vehicles that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards, are eligible for importation into the United States because (1) they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards, and (2) they are capable of being readily altered to conform to the standards.

This action revokes the Class E airspace area at Palmer Metropolitan Airport, MA. This action is prompted by our cancellation of the standard instrument approach procedures to the airport when the airport converted from Instrument Flight Rule (IFR) public use to a Visual Flight Rule (VFR) private use airport.

The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.

The Food and Drug Administration (FDA) is classifying automated fluorescence in situ hybridization (FISH) enumeration 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: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems.'' 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 amending its regulations by reallocating the uses of menhaden oil in food that currently are established in the regulations, with the condition that when menhaden oil is added to food it is not used in combination with other added oils that are significant sources of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to remove text addressing restrictions on the acquisition of totally enclosed lifeboat survival systems. The text proposed for removal is based on fiscal year 1994 and 1995 appropriations act provisions that are no longer considered applicable, or is based on statutory provisions that apply only to the Navy.

DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement Section 843 of the National Defense Authorization Act for Fiscal Year 2005. Section 843 provides for a 5-year extension of the DoD test program for negotiation of comprehensive small business subcontracting plans.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to update text pertaining to contracting by negotiation. This proposed rule is a result of a transformation initiative undertaken by DoD to dramatically change the purpose and content of the DFARS.

DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to update text pertaining to major systems acquisition, earned value management systems, and cost/ schedule status reporting. This rule is a result of a transformation initiative undertaken by DoD to dramatically change the purpose and content of the DFARS.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to update text pertaining to contract modifications. This proposed rule is a result of a transformation initiative undertaken by DoD to dramatically change the purpose and content of the DFARS.

This regulation establishes tolerances for combined residues of dinotefuran, [N-methyl-N'-nitro-N''-((tetrahydro-3- furanyl)methyl)guanidine] and its metabolites DN [1-methyl-3- (tetrahydro-3-furylmethyl)guanidine] and UF [1-methyl-3-(tetrahydro-3- furylmethyl)urea], expressed as dinotefuran in or on vegetable, fruiting, group 8; vegetable, cucurbit, group 9; brassica, head and stem, subgroup 5A; grape; grape, raisin; potato; potato, chips; potato, granules/flakes; tomato, paste; cotton, undelinted seed; cotton, gin byproducts; and for residues of dinotefuran, [N-methyl-N'-nitro-N''- ((tetrahydro-3-furanyl)methyl)guanidine] alone in or on cattle meat, fat, and meat byproducts (mbyp); goat meat, fat, and mbyp; hog meat, fat, and mbyp; horse meat, fat, and mbyp; sheep meat, fat, and mbyp; and milk. Mitsui Chemicals, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

EPA is announcing the meeting of the Forum on State and Tribal Toxics Action (FOSTTA) to enable state and tribal leaders to collaborate with EPA on environmental protection and pollution prevention issues. Representatives and invited guests of the Chemical Information and Management Project, the Pollution Prevention Project, and the Tribal Affairs Project (TAP), components of FOSTTA, will be meeting April 4-5, 2005. The meeting is being held to provide participants an opportunity to have in-depth discussions on issues concerning environmental and human health. This notice announces the location and times for the meeting and sets forth some tentative agenda topics. EPA invites all interested parties to attend the public meeting.

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C 3501 et seq.) EPA is seeking public comment on the following Information Collection Request (ICR): Toxic Substances Control Act (TSCA) Section 5(a)(2) Significant New Use Rules for Existing Chemicals (EPA ICR No. 1188.08, OMB Control No. 2070-0038). This ICR involves a collection activity that is currently approved and scheduled to expire on January 31, 2006. The information collected under this ICR relates to the requirement that persons notify EPA at least 90 days before they manufacture, import, or process a chemical substance for a significant new use, as defined by TSCA section 5. The ICR describes the nature of the information collection activity and its expected burden and costs. Before submitting this ICR to the Office of Management and Budget (OMB) for review and approval under the PRA, EPA is soliciting comments on specific aspects of the collection.

This final rule amends FAA regulations to create a pilot program to test new application and application approval procedures for the passenger facility charge (PFC) program. This pilot program will run for 3 years from the effective date of this rule and is available to non-hub airports. Besides the pilot program, this final rule also contains several changes designed to streamline the PFC application and amendment procedures for all PFC applications and amendments to improve the entire PFC program. The FAA is enacting these changes in response to Congressional direction found in the Vision 100Century of Aviation Reauthorization Act.

As required by section 3132(b)(4) of title 5, United States Code, this gives notice of all positions in the Senior Executive Service (SES) that were career reserved during 2004.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Pharmacogenomic Data Submissions.'' The guidance provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) on what pharmacogenomic data to submit to the agency during the drug development process, the format of submissions, and how the data will be used in regulatory decisionmaking. The guidance is intended to facilitate scientific progress in the area of pharmacogenomics.