2006 – Federal Register Recent Federal Regulation Documents

In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the fifth meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the fifth meeting is to enable the EMTALA TAG to hear additional testimony and further consider written responses from medical societies and other organizations on specific issues considered by the TAG at previous meetings. The public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.

This notice extends the period for comments on proposed Class II definitions and game classification standards published in the Federal Register on May 25, 2006 (71 FR 30232, 71 FR 30238). Additionally, this notice extends the period for comments on proposed Class II technical standards published in the Federal Register on August 11, 2006 (71 FR 46336).

EPA is approving State Implementation Plan (SIP) revisions submitted by the Commonwealth of Pennsylvania. These revisions pertain to nitrogen oxides (NOX) reductions that are required for the Commonwealth to support its approved attainment demonstration for the Philadelphia-Trenton-Wilmington one-hour ozone nonattainment area (the Philadelphia Area); NOX reductions from stationary internal combustion (IC) engines to meet the NOX SIP Call Phase II (Phase II); and NOX reductions from cement kilns to meet the NOX SIP Call. The revisions also include provisions for emission credits for sources that generate zero-emission renewable energy. The intended effect of this action is to approve these revisions into the Pennsylvania SIP. This action is being taken under the Clean Air Act (CAA or the Act). Effective Date: This final rule is effective on October 30, 2006.

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 18, 2006, titled ``Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers'' (71 FR 48354).

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research is announcing the withdrawal of three guidances for industry: ``Providing Submissions in Electronic FormatNDAs,'' ``Providing Regulatory Submissions in Electronic FormatANDAs,'' and ``Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.'' These guidances are being withdrawn because they are no longer consistent with more recent guidance and no longer reflect the agency's preferred format for receiving electronic submissions.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases,'' dated September 2006. This guidance provides recommendations to manufacturers of viral vaccines for the characterization and qualification of cell substrates and viral seeds used in the production of viral vaccines for human use. This draft guidance, when finalized, will replace the information specific to viral vaccines contained in the 1993 document, entitled ``Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.''

The proposed information collection requirement described below has been 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 information is collected from developers, borrowers, sponsors, or project managers. Summaries from this report enables HUD to monitor and evaluate progress toward designated Minority Business Enterprise (MBE) goals of Executive Order 12432. The information is used for the Department's annual report.

This final rule, issued pursuant to sections 8(a) and 8(d) of the Toxic Substances Control Act (TSCA), withdraws certain chemical substances from the category of voluntary High Production Volume (HPV) Challenge Program orphan (unsponsored) chemical substances that would be subject to reporting requirements under TSCA section 8(a) and 8(d). On August 16, 2006, EPA published two final rules both effective September 15, 2006, with certain exceptions: A Preliminary Assessment Information Reporting (PAIR) rule under TSCA section 8(a) (40 CFR part 712), which requires manufacturers (including importers) of chemical substances in the category of voluntary HPV Challenge Program orphan (unsponsored) chemical substances on the Interagency Testing Committee's (ITC) TSCA section 4(e) Priority Testing List to submit a one-time report on general production/importation volume, end use, and exposure-related information to EPA, and a Health and Safety Data Reporting rule under TSCA section 8(d) (40 CFR part 716), which requires manufacturers (including importers) of chemical substances in this category of HPV Challenge Program orphan (unsponsored) chemical substances to submit certain unpublished health and safety data to EPA. On September 15, 2006, EPA published a final rule that delayed the effective date of the rules published August 16, 2006, until September 29, 2006. The chemical substances listed in this final rule are being withdrawn from 40 CFR parts 712 and 716 for good cause as specified in 40 CFR 712.30(c) and 40 CFR 716.105(c) and, consequently, these listed chemical substances will not be subject to the reporting requirements imposed by the TSCA section 8(a) and 8(d) rules published on August 16, 2006.

In accordance with the National Environmental Policy Act of 1969 (NEPA, 42 U.S.C. 4321 et seq.) and the Federal Land Policy and Management Act of 1976 (FLPMA, 43 U.S.C. 1701 et seq.), the Bureau of Land Management (BLM) has prepared a Draft Resource Management Plan/ Environmental Impact Statement (RMP/EIS) for the Bay planning area for lands adjacent to Bristol Bay and Goodnews Bay, Alaska and by this notice is announcing the opening of the comment period.

We are adopting a new airworthiness directive (AD) for certain Air Tractor, Inc. (Air Tractor) Models AT-802 and AT-802A airplanes. This AD requires you to repetitively inspect the attach angles on the firewall mounted hopper rinse tank shelf for damage and/or cracks and replace damaged and/or cracked attach angles with steel attach angles. Replacing the attach angles with steel attach angles terminates the repetitive inspection requirement. Reports of an uncommanded change in the engine power setting caused by separation of the hopper rinse tank shelf from the firewall prompted this AD. We are issuing this AD to detect and correct damage and/or cracks in the attach angles on the firewall mounted hopper rinse tank shelf, which could result in failure of the attach angles. This failure could lead to shelf movement under maneuver load and shifting of the engine power cables, which could result in an uncommanded engine power setting change.

This regulation establishes an exemption from the requirement of a tolerance for residues of soybean oil, ethoxylated; when used as an inert ingredient in a pesticide chemical formulation. Cognis Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA) requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of soybean oil, ethoxylated.

In preparation for the 2006 ICCAT meeting, the Advisory Committee to the U.S. Section to International Commission for the Conservation of Atlantic Tunas (ICCAT) will meet in October 2006.

The Defense Science Board Task Force on Directed Energy will meet in closed session on November 2 and 3, 2006. The location is to be determined. The task force will review directed energy weapon systems and technology application. The mission of the Defense Science Board is to advise the Secretary of Defense and the Under Secretary of Defense for Acquisition, Technology & Logistics on scientific and technical matters as they affect the perceived needs of the Department of Defense. At these meetings, the Defense Science Board Task Force will: Review all surface, sub-surface, air and space DE programs in the Department and other organizations; examine recent supporting technology advancements and their applications with respect to supporting military DE weapon system developments; as well as make recommendations on potential strategic advantage DE weapons can provide with regards to the delivery of precision effects, decreased collateral damage, limiting unintended effects, and decreasing post combat reconstitution costs and efforts. In accordance with Section 10(d) of the Federal Advisory Committee Act, Pub. L. No. 92-463, as amended (5 U.S.C. App. II), it has been determined that these Defense Science Board Task Force meetings concern matters listed in 5 U.S.C. 552b(c)(1) and that, accordingly, the meetings will be closed to the public.

The Defense Science Board Task Force on Energy Strategy will meet in closed session on October 6, 2006; November 29, 2006; and December 14, 2006; at Science Applications International Corporation (SAIC); 8301 Greensboro Drive, McLean, VA. This meeting will specifically identify strategic transition-opportunities inherently offered by technologies that have implications for energy and their systemic second- and third-order effects. The briefings will contain proprietary material from the private business sector. The mission of the Defense Science Board is to advise the Secretary of Defense and the Under Secretary of Defense for Acquisition, Technology & Logistics on scientific and technical matters as they affect the perceived needs of the Department of Defense. At these meetings, the Defense Science Board Task Force will: identify DoD operational and strategic constraints and vulnerabilities created by optimizing tactical platforms and capabilities without regard to energy usage; programs and means for the DoD to reduce its energy demand, particularly on petroleum-based fuels; and examine implications of alternative. In accordance with Section 10(d) of the Federal Advisory Committee Act, P.L. No. 92-463, as amended (5 U.S.C. App. II), it has been determined that these Defense Science Board Task Force meetings concern matters listed in 5 U.S.C. 552b(c)(4) and that, accordingly, the meetings will be closed to the public.