October 3, 2005 – Federal Register Recent Federal Regulation Documents
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Food and Drug Administration's Communication of Drug Safety Information; Public Hearing
The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is announcing a public hearing on the Center's current risk communication strategies for human drugs. The public hearing announced in this notice is part of the agency's ongoing effort to improve CDER's risk communication. The purpose of the public hearing is to obtain public input on CDER's current risk communication tools, identify stakeholders for collaboration and implementation of additional tools, and obtain greater understanding of the strengths and weaknesses of CDER's existing risk communication.
Regulatory and Administrative Waivers Granted for Public and Indian Housing Programs to Assist with Recovery and Relief in Hurricane Katrina Disaster Areas
This notice advises the public of HUD regulations and other administrative requirements governing HUD's Office of Public and Indian Housing (PIH) programs that have been waived in order to facilitate the delivery of safe and decent housing under these programs to families and individuals who have been displaced from their housing by Hurricane Katrina. Entities that administer PIH programs, which include public housing agencies (PHAs), Indian and tribally designated housing entities (TDHEs), and local and tribal governments, and are located in an area declared by the President to be a federal disaster area as a result of Hurricane Katrina, may defer compliance with the regulations and other requirements listed in this notice for an initial period of 12 months or such other period as may be specified in this notice. PIH program administrators that are not located in a disaster area but assisting with Hurricane Katrina recovery and relief may request waiver of the regulations and administrative requirements listed in this notice, and HUD review and response is available through an expedited waiver request and response process. PIH program administrators, located in an area declared a federal disaster area as a result of Hurricane Katrina, or PIH program administrators not located in such an area but assisting with Hurricane Katrina relief and recovery efforts, may request waiver of a regulation or other administrative requirement through the expedited waiver process provided in this notice. This notice applies only to PIH programs or to cross-cutting regulatory or administrative requirements that are applicable to PIH program administrators.
Notice of Submission of Proposed Information Collection to OMB; Application for Healthy Homes and Lead Hazard Control Program Grants
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. This information collection is required in conjunction with the issuance of Notices of Funding Availability announcing grants for Healthy Homes and Lead Hazard Control Programs.
Notice of Proposed Information Collection: Comment Request; Housing Finance Agency Risk-Sharing Program
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.
Notice of HUD's Fiscal Year (FY) 2005 Notice of Funding Availability Policy Requirements and General Section to SuperNOFA for HUD's Discretionary Grant Programs; Housing Opportunities for Persons With AIDS (HOPWA); Second Competition-Extension of Application Deadline
On August 22, 2005, HUD published its NOFA for the Housing Opportunity for Persons With AIDS Program, second competition for Fiscal Year 2005. Because of the effects of Hurricane Katrina, HUD is extending the application deadline for this NOFA.
Initiation of Five-year (“Sunset”) Reviews
In accordance with section 751(c) of the Tariff Act of 1930, as amended (``the Act''), the Department of Commerce (``the Department'') is automatically initiating five-year (``Sunset Reviews'') of the antidumping duty orders listed below. The International Trade Commission (``the Commission'') is publishing concurrently with this notice its notice of Institution of Five-year Review which covers these same orders.
60-Day Notice of Proposed Information Collection: Form DS-86, Statement of Non-Receipt of a Passport, OMB Control Number 1405-0146
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. The purpose of this notice is to allow 60 days for public comment in the Federal Register preceding submission to OMB. We are conducting this process in accordance with the Paperwork Reduction Act of 1995. Title of Information Collection: Statement of Non-Receipt of A Passport OMB Control Number: 1405-0146 Type of Request: Extension of the currently approved collection Originating Office: Bureau of Consular Affairs, Department of State, Passport Services, Office of Field Operations, Field Coordination Division. CA/PPT/FO/FC. Form Number: DS-86 Respondents: Individuals or Households Estimated Number of Respondents: 23,500 Estimated Number of Responses: 23,500 Average Hours Per Response: 1/12 hr. (5 min.) Total Estimated Burden: 2,000 hours annually Frequency: On occasion Obligation to Respond: Required to Obtain a Benefit
Census Advisory Committee of Professional Associations
The U.S. Bureau of the Census (Census Bureau) is giving notice of a meeting of the Census Advisory Committee of Professional Associations. The Committee members will address issues regarding Census Bureau programs and activities related to their areas of expertise. Members will address policy, research, and technical issues related to 2010 Decennial Census Programs, including the American Community Survey. The Committee also will discuss several economic initiatives, as well as issues pertaining to marketing services and measurement of local labor market activity. Last-minute changes to the agenda are possible, which could prevent giving advance notice of schedule adjustments.
Standard Instrument Approach Procedures, Weather Takeoff Minimums; Miscellaneous Amendments
This amendment establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and/or Weather Takeoff Minimums for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, addition of new obstacles, or changes in air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
IFR Altitudes; Miscellaneous Amendments
This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.
Agency Information Collection Activity Under OMB Review, Request for Comments; Clearance of a New Information Collection Activity, Air Carriers Listing of Leading Outsource Maintenance Providers
The FAA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for a new information collection. The FAA will use the data from the proposed collection to target those leading outsource maintenance providers that may have a higher risk level which in turn would merit an increase of FAA surveillance.
Modification of Class E Airspace; Wellington Municipal Airport, KS
An examination of the controlled airspace for Wellington Municipal Airport, KS has revealed a discrepancy in the Airport Reference Point (ARP) and the size of the Class E airspace area. This action corrects the ARP and modifies the size of the Class E5 airspace area beginning at 700 feet above the surface. The radius of the airspace area is expanded from within a 6.3-mile radius to within a 6.4 mile radius of the airport. This action brings the Class E5 airspace area into compliance with FAA directives.
Modification of Class E Airspace; Sheldon Municipal Airport, IA
This action modifies the size of the Class E5 airspace area beginning at 700 feet above the surface at Sheldon, IA to contain Instrument Flight Rule (IFR) operations in controlled airspace. The radius of the airspace area is expanded from within a 6.4-mile radius to within a 6.9-mile radius of the airport. This action brings the Class E5 airspace area into compliance with FAA directives.
Industries in American Samoa; Wage Order
The Department of Labor (DOL) is amending regulations to implement changes in the minimum wage rates applicable to various industry classifications in American Samoa under the Fair Labor Standards Act (FLSA). The FLSA provides for a special industry committee appointed by the Secretary of Labor to determine minimum wage rates in American Samoa. Industry Committee for All Industries in American Samoa No. 26 (the Committee) met in public and executive session in Pago Pago, American Samoa during the week of June 20, 2005.
Indian Gaming
Notice is given that the Tribal-State compact between the Thlopthlocco Tribal Town and the State of Oklahoma, and the Tribal- State compact between the Ponca Tribe of Oklahoma and the State of Oklahoma are considered to have been approved and are in effect.
Marine Mammals; File No. 774-1649-03
Notice is hereby given that the Southwest Fisheries Science Center, National Marine Fisheries Service, 8604 La Jolla Shores Drive, La Jolla, California 92038 (Principal Investigator: Rennie Holt, Ph.D.) has requested an amendment to scientific research Permit No. 774-1649- 02.
Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled ``Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule.
Endangered Fish and Wildlife; Marine Mammal Protection Act; Proposed Conservation Plan for Southern Resident Killer Whales
The Marine Mammal Protection Act (MMPA) of 1972, as amended, requires the Secretary of Commerce to prepare a conservation plan for any species or stock of marine mammals designated as depleted under the Act. The Southern Resident stock of killer whales (Orcinus orca) was designated as depleted on May 29, 2003, and a conservation plan was developed to promote the conservation and recovery of these whales. NMFS announces the availability for public review of the Proposed Conservation Plan for Southern Resident Killer Whales (Plan). NMFS is requesting review and comment on the Plan from the public and all interested parties.
Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Canada's Original ICEBERG Water Corp., to market a product designated as ``Canada's Original Iceberg Water'' that deviates from the U.S. standard of identity for bottled water. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility.
Draft Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods'' dated September 2005. The draft guidance provides blood establishments and FDA staff revised recommendations for the collection of Platelets by automated methods (plateletpheresis). The draft guidance is intended to help blood establishments ensure donor safety and the safety, purity, and potency of Platelets collected by an automated blood cell separator device. For the purpose of this document, Platelets collected by automated methods will be referred to by the product name ``Platelets, Pheresis.'' The draft guidance contains recommendations for appropriate criteria for a biologics license application or supplement for manufacturing Platelets, Pheresis. When finalized, this draft guidance will replace the October 1988 ``Revised Guideline for the Collection of Platelets, Pheresis.''
Announcement of Establishment of the Federal Motor Carrier Safety Administration Medical Review Board; Request for Nominations
FMCSA announces the establishment of a Medical Review Board as requested by the recent passage of Safe, Accountable, Flexible, and Efficient Transportation Equity Act; A Legacy for Users (SAFETEA-LU). The Medical Review Board will provide scientific advice to The Secretary of Transportation and the Administrator of FMCSA on medical issues including the physical qualification requirements for commercial motor vehicle (CMV) operators. This announcement provides details about the purpose and functions of the FMCSA Medical Review Board, in accordance with the Federal Advisory Committee Act (FACA). This notice also discusses the Agency's medical research priorities and solicits applications from interested physicians to serve on the Medical Review Board. The Secretary of Transportation will appoint five physicians to the Medical Review Board, and the board will begin work in fiscal year 2006.
Endangered and Threatened Species; Take of Anadromous Fish
Notice is hereby given that the Oregon Department of Fish and Wildlife (ODFW) has submitted a Fishery Management and Evaluation Plan (FMEP) and the Washington Department of Fish and Wildlife (WDFW) has submitted an amendment to an FMEP pursuant to the protective regulations promulgated for Lower Columbia River (LCR) coho salmon under the Endangered Species Act. The FMEPs specify the future management of inland recreational fisheries potentially affecting LCR coho salmon. This document serves to notify the public of the availability of the FMEPs for review and comment before final approval or disapproval is made by NMFS.
Business and Industry Guaranteed Loan Program Annual Renewal Fee
In this final rule the Rural Business-Cooperative Service (the Agency) amends its regulation for the Business and Industry (B&I) Guaranteed Loan Program to provide the authority for the charging of an annual renewal fee on all loans obligated after the publication of the final rule. This annual renewal fee is in addition to the existing one- time guarantee fee. Changes to modify the program regulations were originally proposed on February 28, 2005. The intended effect of this rule is to reduce the subsidy rate for guaranteed loans allowing the budget authority dollar level to support a greater level of assistance to the public (i.e., higher supportable loan level). A notice will be published in the Federal Register each fiscal year that will establish the guarantee fee rate and any annual renewal fee rate for loans obligated during that fiscal year.
Exemption to Prohibition on Circumvention of Copyright Protection Systems for Access Control Technologies
The Copyright Office of the Library of Congress is preparing to conduct proceedings in accordance with section 1201(a)(1) of the Copyright Act, which was added by the Digital Millennium Copyright Act and which provides that the Librarian of Congress may exempt certain classes of works from the prohibition against circumvention of technological measures that control access to copyrighted works. The purpose of this rulemaking proceeding is to determine whether there are particular classes of works as to which users are, or are likely to be, adversely affected in their ability to make noninfringing uses due to the prohibition on circumvention. This notice requests written comments from all interested parties, including representatives of copyright owners, educational institutions, libraries and archives, scholars, researchers and members of the public, in order to elicit evidence on whether noninfringing uses of certain classes of works are, or are likely to be, adversely affected by this prohibition on the circumvention of measures that control access to copyrighted works.
Fisheries of the Economic Exclusive Zone Off Alaska; Pacific Ocean Perch in the Western Aleutian District of the Bering Sea and Aleutian Islands Management Area
NMFS is opening directed fishing for Pacific ocean perch in the Western Aleutian District of the Bering Sea and Aleutian Islands Management Area (BSAI). This action is necessary to allow the Pacific ocean perch fishery in the Western Aleutian District of the BSAI to resume.
Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Extension of Emergency Fishery Closure Due to the Presence of the Toxin That Causes Paralytic Shellfish Poisoning
The regulations contained in the temporary rule, emergency action, published on September 9, 2005, at the request of the U.S. Food and Drug Administration (FDA), continue through December 31, 2005. In that action NMFS reopened a portion of Federal waters of the Gulf of Maine, Georges Bank, and southern New England that it had previously closed from June 14, 2005, through September 30, 2005, to the harvest for human consumption of certain bivalve molluscan shellfish due to the presence in those waters of the toxin that causes Paralytic Shellfish Poisoning (PSP). The FDA has determined that there is insufficient analytical data to support the scheduled reopening of the entire area to all bivalve molluscan shellfish fishing on October 1, 2005.
South Atlantic Fishery Management Council; Law Enforcement Committee and Advisory Panel Meeting
The South Atlantic Fishery Management Council (Council) will hold a joint meeting of its Law Enforcement Committee and Advisory Panel (AP) in Charleston, South Carolina.
Meeting of the Ozone Transport Commission
The United States Environmental Protection Agency is announcing the 2005 Fall Meeting of the Ozone Transport Commission (OTC). This OTC meeting will explore options available for reducing ground-level ozone precursors in a multi-pollutant context.
National and Governmental Advisory Committees to the U.S. Representative to the Commission for Environmental Cooperation
Under the Federal Advisory Committee Act, Public Law 92463, EPA gives notice of a meeting of the National Advisory Committee (NAC) and Governmental Advisory Committee (GAC) to the U.S. Representative to the North American Commission for Environmental Cooperation (CEC). The National and Governmental Advisory Committees advise the EPA Administrator in his capacity as the U.S. Representative to the CEC Council. The Committees are authorized under Articles 17 and 18 of the North American Agreement on Environmental Cooperation (NAAEC), North American Free Trade Agreement Implementation Act, Public Law 103-182, and as directed by Executive Order 12915, entitled ``Federal Implementation of the North American Agreement on Environmental Cooperation.'' The Committees are responsible for providing advice to the U.S. Representative on a wide range of strategic, scientific, technological, regulatory, and economic issues related to implementation and further elaboration of the NAAEC. The NAC is composed of 12 members representing academia, environmental non- governmental organizations, and private industry. The GAC consists of 12 members representing state, local, and tribal governments. The purpose of the meeting is to discuss policy issues associated with the CEC's Draft 2006 Operational Plan and Budget. A copy of the agenda for the meeting will be posted at https://www.epa.gov/ocem/nacgac-page.htm.
National Emission Standards for Hazardous Air Pollutants for Secondary Aluminum Production
The EPA is proposing amendments to the national emission standards for hazardous air pollutants (NESHAP) for secondary aluminum production, which were issued on March 23, 2000 under section 112 of the Clean Air Act (CAA), and amended on December 30, 2002. This action proposes to correct a punctuation error in the definition of ``clean charge'' and a typographical error in the operating temperature of a scrap dryer/delacquering kiln/decoating kiln afterburner. 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 we anticipate no adverse comments. We have explained our reasons for the proposed amendments in the preamble to 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 the amendments. We will publish a timely withdrawal in the Federal Register indicating that the amendments are being withdrawn. If the direct final rule amendments in the Rules and Regulations section of this Federal Register are withdrawn, all comments will be addressed in a subsequent final action 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. The regulatory text for the proposal is identical to that for the direct final rule published in the Rules and Regulations section of this Federal Register. For further supplementary information, see the direct final rule.
National Emission Standards for Hazardous Air Pollutants for Secondary Aluminum Production
On March 23, 2000, EPA promulgated national emission standards for hazardous air pollutants (NESHAP) for secondary aluminum production under section 112 of the Clean Air Act (CAA), and on December 30, 2002, we published final amendments to the standards based on two separate settlement agreements. This amendment corrects a punctuation error in the definition of ``clean charge'' previously promulgated in the December 30, 2002 amendments and a typographical error in the operating temperature of a scrap dryer/delacquering kiln/decoating kiln afterburner. We are making the amendment by direct final rule, without prior proposal, because we view the revision as noncontroversial and anticipate no adverse comments. However, in the Proposed Rules section of this Federal Register, we are publishing a separate document that will serve as the proposal to amend the national emission standards for secondary aluminum production, if adverse comments are filed. If we receive any adverse comments on the direct final rule, we will publish a timely withdrawal in the Federal Register informing the public that the amendments are being withdrawn due to adverse comment. We will address all public comments in a subsequent final rule based on the proposed rule. If we do not receive adverse comment on the direct final rule, it will become effective on the date set out below. We will not institute a second comment period on the direct final rule. Any parties interested in commenting must do so at this time.
Approval and Promulgation of Implementation Plans; New York State Implementation Plan Revision
The Environmental Protection Agency is approving a revision to the New York State Implementation Plan (SIP) concerning New York's permitting program. The SIP revision consists of amendments to Title 6 of the New York Code, Rules and Regulations, Part 201, ``Permits and Certificates.'' The intended effect of this approval is to incorporate administrative changes to New York's permitting program into the SIP.
Partial Approval and Partial Disapproval of Implementation Plans; State of Missouri
This action proposes to partially approve and partially disapprove a State Implementation Plan (SIP) submission by the state of Missouri which revises the Restriction of Emission of Sulfur Compounds rule. The Missouri rule establishes general requirements for emissions of sulfur compounds from various source categories, and establishes specific emissions requirements for certain named sources. We propose to approve most of the revisions to the rule because they involve clarifications, updates, and other improvements to the current rule. This proposed action does not include a portion of the rule that regulates ambient concentrations of sulfur compounds, because this provision is not in the current SIP, and we do not directly enforce Missouri's Air Quality Standards. We propose to disapprove revisions to two source-specific references because the state has not demonstrated that the revisions are protective of the short-term SO2 National Ambient Air Quality Standards (NAAQS).
Petition To Reopen Record
This document provides the public with notice that a petition seeking to reopen the record in the Commission's pending reconsideration of the Bank One negotiated service agreement has been filed. It notes that the petition, if granted, could expand the scope of reconsideration. It also notes that a companion notice of inquiry has been issued and identifies several new or revised comment deadlines.
Certain Optical Disk Controller Chips and Chipsets and Products Containing Same, Including DVD Players and PC Optical Storage Devices; Notice of Final Determination; Issuance of Limited Exclusion Order and Cease and Desist Orders; Termination of Investigation
Notice is hereby given that the U.S. International Trade Commission has found a violation of section 337 of the Tariff Act of 1930 (19 U.S.C. 337) based on the infringement of one asserted claim of one asserted patent and has issued a limited exclusion order and cease and desist orders in the above-captioned investigation.
Intent To Prepare a Draft Environmental Impact Statement, Programmatic Sediment Management Plan, Lower Snake River Reservoirs, in the States of Washington and Idaho
The U.S. Army Corps of Engineers (Corps) intends to prepare an Environmental Impact Statement (EIS) for a Programmatic Sediment Management Plan that will address sediment management within the four lower Snake River reservoirs and that portion of McNary reservoir contained within the lower Snake River The plan will identify and evaluate ways the Corps can manage sediment within these reservoirs and examine the sediment input (sources) on a programmatic basis in the near-term, mid-term, and long-term. The reservoirs extend from the mouth of the Snake River upstream to the communities of Lewiston, Idaho, and Clarkston, Washington; and include the lower 2 miles of the Clearwater River from its confluence with the Snake River at Lewiston upstream to the U.S. Highway 12 Bridge. In the plan the Corps will also include all tributaries that could significantly contribute sediment to the lower Snake River. The Corps is preparing this plan because sediment management has been an ongoing maintenance issue since the completion of Ice Harbor Dam, the first dam and reservoir on the lower Snake River, in 1961. Rather than addressing sediment-related problems on a case-by-case basis, the Corps has determined that it would be more effective to evaluate sediment management as a whole and on a watershed basis. The intent of the plan is to identify ways to reduce the amount of sediment entering the reservoirs, identify how to manage the sediment once it enters the reservoirs, and identify possible changes to structures or operations to reduce maintenance and associated impacts while still providing for authorized project purposes, including navigation.
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