February 9, 2005 – Federal Register Recent Federal Regulation Documents

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): Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment (Toxic Substances Control Act (TSCA) section 8(c)) (EPA ICR No. 1031.08, OMB Control No. 2070-0017). This ICR involves a collection activity that is currently approved and scheduled to expire on December 31, 2005. The information collected under this ICR relates to requirements under TSCA section 8(c) that companies that manufacture, process, or distribute in commerce any chemical substance or mixture maintain records of significant adverse reactions to health or the environment alleged to have been caused by such substance or mixture. 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.

EPA is proposing to approve the attainment demonstration State Implementation Plan (SIP) revisions submitted by the Commonwealth of Virginia and the District of Columbia for the Metropolitan Washington, D.C. severe 1-hour ozone nonattainment area (the Washington area). EPA is proposing to approve the attainment demonstration SIP revisions submitted by the State of Maryland for the Washington area contingent upon the State submitting an approvable SIP revision for certain penalty fees, required by the Clean Air Act (the Act), prior to the time EPA issues a final rule on Maryland's attainment demonstration. In the alternative, EPA is proposing to disapprove the attainment demonstration SIP revision submitted by the State of Maryland for the Washington area. In the event we issue a final rule disapproving Maryland's attainment demonstration for the State's failure to satisfy the Act's penalty fee provisions, EPA is also proposing to issue a protective finding to preclude a ``conformity freeze'' pursuant to the transportation conformity rule. These revisions are being proposed in accordance with the Act.

The Bureau of Land Management (BLM) will file the plat of survey of the lands described below in the BLM-Eastern States, Springfield, Virginia, 30 calendar days from the date of publication in the Federal Register.

The Commission adopted new rules and policies pertaining to portable Global Mobile Personal Communications by Satellite (GMPCS) transceivers, i.e., satellite telephones and other portable transceivers operated by end users for communication via direct radio links with satellites. These devices are used for both voice and data communication and may be used for internet access or other modes of broadband communication. Certain rules contained new information collection requirements and were published in the Federal Register on February 6, 2004. This document announces the effective date of these published rules.

The authority for the Demonstration Project has been extended with respect to chiropractors (see legislative authority below). The Health Resources and Services Administration (HRSA) announces that applications from qualified chiropractors who agree to serve underserved populations in Primary Care Health Professional Shortage Areas (HPSAs) throughout the Nation will be accepted by the National Health Service Corps (NHSC) for loan repayment awards. A two-year service commitment is required. There is no guarantee that participants in this demonstration project will have an opportunity to continue their service and loan repayments beyond the initial two-year service period. Chiropractors, with qualifying educational loans, must serve at organized primary health care sites in Primary Care HPSAs that have another NHSC clinician on staff who will be concurrently fulfilling an NHSC service commitment through the scholarship or loan repayment program and who is licensed to prescribe medications. This demonstration project will include an evaluation component to determine whether adding chiropractors as permanent NHSC members would enhance the effectiveness of the NHSC. A maximum of 40 individuals will be awarded loan repayment contracts under this demonstration project. Purpose: Eligible chiropractors will participate in the Loan Repayment Demonstration Project to determine whether their services will enhance the effectiveness of the NHSC. Legislative Authority: These applications are solicited under section 338L of the Public Health Service (PHS) Act, as amended by Public Law. 107-251 and Public Law 108-447. See also H.R. Conf. Rep. No. 108-792, at 1113, 1155 (2004); S. Rep. No. 108-345, at 41-42 (2004). Eligible Applicants: Eligible applicants must (1) be citizens or nationals of the United States, (2) possess a current unrestricted license to practice as a chiropractor in the State in which they intend to practice, (3) be negotiating or have secured employment at an eligible community site, and (4) meet the additional eligibility requirements outlined in the application materials. Chiropractors must also have a doctor of chiropractic degree from a four-year chiropractic college that is currently fully accredited by the Commission on Accreditation of the Council on Chiropractic Education, and successfully passed the entire examination by the National Board of Chiropractic Examiners. Funding Priorities or Preferences: Priority will be given to (A) applicants who have characteristics that increase the probability of their continuing to practice in HPSAs after they have completed service, and (B) subject to paragraph (A), applicants from disadvantaged backgrounds. A funding preference will also be given to applicants serving Primary Care HPSAs of greatest shortage (based on the HPSA scores). Statutory Matching or Cost Sharing Requirement: None. Review Criteria: Loan repayment applications will be evaluated to determine (1) the eligibility of the applicant, and (2) the applicant's priority for funding. Estimated Amount of this Competition: $2,000,000. Estimated Number of Awards: 40. Estimated or Average Size of Each Award: $50,000. Estimated Project Period: 2 years. Application Requests, Availability, Dates and Addresses: Application materials are available for downloading via the Web at https://nhsc.bhpr.hrsa.gov. Applicants may also request a hard copy of the application materials by contacting the National Health Service Corps at 1-800-638-0824. All application materials must be submitted in hard copy format. In order to be considered for an award, applications from chiropractors must be postmarked or delivered to the HRSA National Health Service Corps by no later than June 17, 2005 at 5 p.m. ET. Completed applications must be mailed or delivered to: Division of National Health Service Corps, NHSC Loan Repayment Program, c/o I.Q. Solutions, 11300 Rockville Pike, Suite 901, Rockville, MD, 20852. Applicants should request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing. Applications postmarked or submitted after the deadline date, or sent to any address other than that above, will be returned to the applicant and not processed. The NHSC will acknowledge receipt of the application if the applicant chooses to complete the notification postcard that is included in the application materials. Application Availability Date: February 2005. Application Deadline: June 17, 2005 at 5 p.m. et. Projected Award Date: September 30, 2005.

The USDA Forest Service Plumas National Forest will prepare an Environmental Impact Statement (EIS) on a proposal to construct a Defensible Fuel Profile Zone (DFPZ), harvest trees using group- selection and individual tree selection silvicultural methods, and perform associated road-system improvement work in forested areas of public land northeast of Quincy, California.

The U.S. Fish and Wildlife Service (Service, we) announces the availability of the Draft Recovery Plan for the Kaua`i Cave Arthropods: the Kaua`i Cave Wolf Spider (Adelocosa anops) and the Kaua`i Cave Amphipod (Spelaeorchestia koloana) for public review and comment.

The Alcohol and Tobacco Tax and Trade Bureau proposes to establish the ``Niagara Escarpment'' viticultural area in Niagara County, New York. We designate viticultural areas to allow bottlers to better describe the origin of wines and to allow consumers to better identify the wines they may purchase. We invite comments on this proposed addition to our regulations.

Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Pub. L. 106-393), the Boise and Payette National Forests' Southwest Idaho Resource Advisory Committee will conduct a business meeting, which is open to the public.

In accordance with the requirements of the National Environmental Policy Act, the U.S. Army Corps of Engineers (USACE), Baltimore District has prepared a Draft Tiered Environmental Impact statement (TEIS) and Dredged Material Management Plan (DMMP) to analyze dredged material placement for the Port of Baltimore for 20 years of maintenance and new work dredging. USACE is making the document available to the public for review and comment through a Notice of Availability published in the Federal Register. The overall goal of the DMMP is to develop a plan to maintain, in an economically and environmentally sound manner, channels necessary for navigation for the Port of Baltimore, conduct dredged material placement in the most environmentally sound manner, and maximize the use of dredged material as a beneficial resource. The recommendations which will provide a minimum of 20 years of dredged material placement capacity for the Port of Baltimore are: Continued use of open water placement in Virginia (Dam Neck Open Water Placement; Rappahannock Shoal Deep Alternate Open Water Placement; and Wolf Trap Alternate Open Water Placement). Optimized use of existing dredged material management sites in Maryland, including Pooles Island Open Water Site, Hart-Miller Island Dredged Material Containment Facility, Cox Creek Confined Disposal Facility and Poplar Island Environmental Restoration Project (PIERP). Multiple confined disposal facilities for harbor material in Patapsco River. Large Island Restoration-Middle Chesapeake Bay. PIERP Expansion. Wetland Restoration-Dorchester County. We are making the Draft TEIS available to the public for a 45-day review and comment period.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register Notice with a 60-day comment period was published on August 6, 2004 [FR Doc. 04-17991, Vol. 69, No. 151, Page 47980].

The Board of Governors of the Federal Reserve System (Board) has adopted final amendments to its Regulation A to reflect the Board's approval of an increase in the primary credit rate at each Federal Reserve Bank. The secondary credit rate at each Reserve Bank automatically increased by formula as a result of the Board's primary credit rate action.

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (ID) issued by the presiding administrative law judge (ALJ) granting the motion of Alan Lee Distributors, Inc. (ADI) for summary determination of non-infringement in the above-captioned investigation.

South Carolina has applied to EPA for Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA has determined that these changes satisfy all requirements needed to qualify for Final authorization, and is authorizing the State's changes through this immediate final action. EPA is publishing this rule to authorize the changes without a prior proposal because we believe this action is not controversial and do not expect comments that oppose it. Unless we get written comments which oppose this authorization during the comment period, the decision to authorize South Carolina's changes to their hazardous waste program will take effect. If we get comments that oppose this action, we will publish a document in the Federal Register withdrawing this rule before it takes effect and a separate document in the proposed rules section of this Federal Register will serve as a proposal to authorize the changes.

The United States Environmental Protection Agency's (EPA) Environmental Financial Advisory Board (EFAB) will hold an open meeting. EFAB is an EPA advisory committee chartered under the Federal Advisory Committee Act (FACA) to provide advice and recommendations to EPA on creative approaches to funding environmental programs, projects, and activities. EFAB is chartered with providing analysis and advice to the EPA Administrator and program offices on environmental finance. The purpose of this meeting is to hear from informed speakers on environmental finance issues, proposed legislation and Agency priorities and to discuss progress with work products under EFAB's current strategic action agenda. Environmental financing topics expected to be discussed include: Joint Operations of the State Revolving Fund Programs, Innovations in Watershed Financing, Affordability of Water and Wastewater, Innovative Financing Tools, Preventing Future Non-Funded Abandoned Sites (Financial Assurance), and Useful Life Financing of Environmental Facilities. The meeting is open to the public; however, seating is limited. All members of the public who wish to attend the meeting must register in advance, no later than Tuesday, March 8, 2005.

This is a Notice of the Presidential declaration of a major disaster for the State of Indiana (FEMA-1573-DR), dated 01/21/2005. Incident: Severe Winter Storms and Flooding. Incident Period: 01/01/2005 and continuing. Effective Dates: 01/21/2005. Physical Loan Application Deadline Date: 03/22/2005. EIDL Loan Application Deadline Date: 10/21/2005.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Schering-Plough Animal Health Corp. The supplemental NADAs provide for the addition of statements to labeling of subcutaneous implants containing zeranol warning against the use of these products in calves to be processed for veal.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q8 Pharmaceutical Development.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance describes the suggested contents for the pharmaceutical development section in the quality module of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The draft guidance is intended to assist in the development of pharmaceutical studies that provide scientific understanding to support the establishment of specifications and manufacturing controls and serve as the basis for evaluating risk management over the life cycle of the product.