January 12, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on regulations requiring the distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information.

In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing temporary regulations relating to the requirements for filing corporate income tax returns, S corporation returns, and returns of organizations required under section 6033 on magnetic media under section 6011(e) of the Internal Revenue Code (Code). The text of those regulations also serves as the text of these proposed regulations. This document also provides notice of a public hearing on these proposed regulations.

An open meeting of the Ad Hoc Committee of the Taxpayer Advocacy Panel will be conducted (via teleconference). The TAP will be discussing issues pertaining to lessoning the burden for individuals. Recommendations for IRS systemic changes will be developed.

An Open Meeting of the Area 1 Taxpayer Advocacy Panel will be conducted (via teleconference). The Taxpayer Advocacy Panel is soliciting public comments, ideas and suggestions on improving customer service at the Internal Revenue Service.

This document contains proposed regulations relating to the disclosure of returns and return information pursuant to section 6103(n) of the Internal Revenue Code (Code). The proposed regulations describe the circumstances under which officers or employees of the Treasury Department, a State tax agency, the Social Security Administration, or the Department of Justice may disclose returns and return information to obtain property or services for tax administration purposes, pursuant to a written contract or agreement. The proposed regulations clarify the existing regulations with respect to redisclosures of returns or return information by contractors, especially with regard to redisclosures by contractors to agents or subcontractors, and clarify that the civil and criminal penalties of sections 7431, 7213, and 7213A apply to the agents or subcontractors. The proposed regulations also clarify that section 6103(n) applies to written contracts or agreements that are entered into to obtain property or services for purposes of tax administration, including contracts that are not awarded under the Federal Acquisition Regulations (FAR), 48 CFR pts. 1 through 53. The proposed regulations will affect officers and employees of the Treasury Department, a State tax agency, the Social Security Administration, or the Department of Justice who disclose returns or return information in connection with a written contract or agreement for the acquisition of property or services for tax administration purposes. The proposed regulations will also affect any person, or officer, employee, agent, or subcontractor of the person, or officer or employee of the agent or subcontractor, who receives returns or return information in connection with a written contract or agreement for the acquisition of property or services.

The California Air Resources Board (CARB), has requested EPA authorization, under section 209(e) of the Clean Air Act (Act), for CARB to enforce California's Marine Spark Ignition Engine regulations for outboard marine engines, personal watercraft, and inboard and sterndrive marine engines, and to enforce California's Off-Road Large Spark Ignition Engine regulations. As the Act requires, EPA is announcing the opportunity for a public hearing and requesting public comment on each of these CARB requests.

NMFS is required to specify annual catch quotas for the Atlantic surfclam and ocean quahog fisheries. NMFS issues this rule to set final allowable harvest levels of Atlantic surfclams and ocean quahogs from the Exclusive Economic Zone and an allowable harvest level of Maine mahogany ocean quahogs from Atlantic waters north of 43[deg]50' N. lat. for the 2005, 2006, and 2007 fishing years.

In accordance with provisions of the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that an Incidental Harassment Authorization (IHA) has been issued to the California Department of Transportation (CALTRANS) to take small numbers of California sea lions, Pacific harbor seals, and gray whales, by harassment, incidental to construction of a replacement bridge for the East Span of the San Francisco-Oakland Bay Bridge (SF-OBB) in California.

This notice announces that pesticide related information submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), including information that may have been claimed as Confidential Business Information (CBI) by the submitter, will be tranferred to Systalex Corp. in accordance with 40 CFR 2.307(h)(3) and 2.308(i)(2). Systalex Corp. has been awarded multiple contracts to perform work for OPP, and access to this information will enable Systalex Corp. to fulfill the obligations of the contract.

EPA is correcting certain language that was inadvertently changed from the March 16, 1978, TSCA Section 8(e) Statement of Interpretation and Enforcement Policy; Notification of Substantial Risk (1978 TSCA Section 8(e) Policy Statement) when the Agency issued its TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance (2003 guidance document) on June 3, 2003. The 2003 guidance document clarified certain aspects of TSCA section 8(e) reporting guidance and included a re-publication of major portions of the Agency's 1978 TSCA Section 8(e) Policy Statement. This notice merely re-inserts, verbatim, certain language from the 1978 TSCA Section 8(e) Policy Statement into the June 3, 2003, guidance document. This notice also clarifies the applicability date of the June 3, 2003 guidance document, and announces the addition of questions and answers on the reportability of environmental releases to the Q&A section of the TSCA section 8(e) web page (https://www.epa.gov/oppt/tsca8e/).

EPA is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of Maryland, Commonwealth of Virginia and the District of Columbia for the Metropolitan Washington, DC severe 1-hour ozone nonattainment area (the Washington area). These revisions include the post 1996-1999 and post 1999-2005 rate-of-progress (ROP) plans, changes to the 1990 base year inventory, a contingency measures plan, certain transportation control measures (TCMs), and a demonstration that each SIP contains sufficient transportation control measures to offset growth in vehicle miles traveled (VMT) as necessary to demonstrate ROP and attainment of the 1-hour national ambient air quality standard (NAAQS) for ozone. The intended effect of this action is to propose approval of revisions submitted to satisfy the SIP requirements of 1-hour ozone nonattainment areas classified as severe. These revisions are being proposed for approval in accordance with the Clean Air Act (CAA or the Act).

The FAA proposes to adopt a new airworthiness directive (AD) for certain McDonnell Douglas transport category airplanes. This proposed AD would require doing repetitive detailed inspections for accumulation of debris (blockage) of the drain holes of the pitot tubes, and cleaning if any evidence of debris is found. This proposed AD is prompted by reports of blocked drain holes of the pitot tubes. We are proposing this AD to prevent blocked drain holes of the pitot tubes, which could result in the accumulation of water in the pitot- static system and consequent failure of that system. Failure of the pitot-static system could result in erroneous airspeed indications in the cockpit and consequent loss of airspeed control.

This action withdraws a notice of proposed rulemaking (NPRM) that proposed a new airworthiness directive (AD), applicable to certain McDonnell Douglas Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD- 83), DC-9-87 (MD-87), and MD-88 airplanes. That action would have required installing shield assemblies for power feeder cables in the forward and aft lower cargo compartments, and installing an additional shield for the power feeder cable of the auxiliary power unit in the aft lower cargo compartment. Since the issuance of the NPRM, the Federal Aviation Administration (FAA) has determined that the proposed requirements are included in the requirements of another existing AD; the NPRM does not contain any new requirements beyond those of the existing AD. Accordingly, the proposed rule is withdrawn.

Deleta Earle (Applicant) requests an incidental take permit (ITP) pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973 (U.S.C. 1531 et seq.), as amended (Act). The Applicant anticipates taking about 0.23 acre of Florida scrub-jay (Aphelocoma coerulescens) (scrub-jay) foraging, sheltering, and possibly nesting habitat incidental to lot preparation for the construction of a single-family home and supporting infrastructure in Brevard County, Florida (Project). The destruction of 0.23 acre of foraging, sheltering, and possibly nesting habitat is expected to result in the take of one family of scrub-jays. The Applicant's Habitat Conservation Plan (HCP) describes the mitigation and minimization measures proposed to address the effects of the Project to the Florida scrub-jay. These measures are outlined in the SUPPLEMENTARY INFORMATION section below. We have determined that the Applicant's proposal, including the proposed mitigation and minimization measures, will individually and cumulatively have a minor or negligible effect on the species covered in the HCP. Therefore, the ITP is a ``low-effect'' project and qualifies as a categorical exclusion under the National Environmental Policy Act (NEPA), as provided by the Department of Interior Manual (516 DM2, Appendix 1 and 516 DM 6, Appendix 1). We announce the availability of the HCP for the incidental take application. Copies of the HCP may be obtained by making a request to the Regional Office (see ADDRESSES). Requests must be in writing to be processed. This notice is provided pursuant to section 10 of the Endangered Species Act and NEPA regulations (40 CFR 1506.6).

The Ravalli County Resource Advisory Committee will be meeting to discuss project development for 2005 and project updates for 2004. Agenda topics will include electing a chairperson for 2005, public outreach methods, and a public forum (question and answer session). The meeting is being held pursuant to the authorities in the Federal Advisory Committee Act (Public Law 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Pub. L. 106-393). The meeting is open to the public.

This notice advises the public that Westlake Ranch LLC and Randy and Tasha Curs (Applicants) have applied to the Fish and Wildlife Service (Service) for an incidental take permit (ITP), pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973, as amended (Act). The requested 50-year permit would authorize the incidental take of the threatened Oregon silverspot butterfly (Speyeria zerene hippolyta, ``butterfly''), associated with the construction and residential development of 75 lots on approximately 165 acres, five miles north of the city of Gearhart, in Clatsop County, Oregon. We are requesting comments on the permit application and on whether the proposed Habitat Conservation Plan (HCP) qualifies as a ``low effect'' HCP, eligible for a categorical exclusion under the National Environmental Policy Act (NEPA) of 1969, as amended. We explain the basis for this possible determination in a draft Environmental Action Statement (EAS), which is also available for public review.

The U.S. Census Bureau (Census Bureau) proposes to amend the Foreign Trade Statistics Regulations (FTSR) to incorporate the requirement for reporting the Kimberley Process Certificate (KPC) number for the exports (reexports) of rough diamonds filed through the Automated Export System (AES) in accordance with the Clean Diamond Trade Act. This rule would serve to carry out the purposes of Executive Order 13312 of July 29, 2003, which implemented the Clean Diamond Trade Act and the Kimberley Process Certification Scheme in the United States.