April 14, 2005 – Federal Register Recent Federal Regulation Documents

Draft Guidance for Industry on Exploratory Investigational New Drugs Studies; Availability
Document Number: 05-7485
Type: Notice
Date: 2005-04-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Exploratory IND Studies.'' This draft guidance clarifies what preclinical and clinical issues (including chemistry, manufacturing, and controls issues) should be considered when planning exploratory studies in humans, including studies of closely related drugs or biologics, under an investigational new drug (IND) application. This draft guidance emphasizes the concept that limited investigations in humans can be initiated with more limited preclinical support because such studies present fewer potential risks than do traditional phase 1 studies that look for dose-limiting toxicities.
Airworthiness Directives; Learjet Model 23, 24, 24A, 24B, 24B-A, 24D, 24D-A, 24E, 24F, 25, 25A, 25B, 25C, 25D, and 25F Airplanes Modified by Supplemental Type Certificate SA1731SW, SA1669SW, or SA1670SW
Document Number: 05-7484
Type: Proposed Rule
Date: 2005-04-14
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for certain Learjet Model 23, 24, 24A, 24B, 24B-A, 24D, 24D-A, 24E, 24F, 25, 25A, 25B, 25C, 25D, and 25F airplanes. This proposed AD would require removing the thrust reverser accumulator, and making the thrust reverser hydraulic system and the thrust reversers inoperable. This proposed AD is prompted by reports of the failure of two thrust reverser accumulators. We are proposing this AD to prevent failure of the thrust reverser accumulators, due to fatigue cracking on the female threads, which could result in the loss of hydraulic power and damage to the surrounding airplane structure.
Airworthiness Directives; British Aerospace Model BAe 146 and Model Avro 146-RJ Series Airplanes
Document Number: 05-7483
Type: Rule
Date: 2005-04-14
Agency: Federal Aviation Administration, Department of Transportation
The FAA is correcting a typographical error in an existing airworthiness directive (AD) that was published in the Federal Register on March 28, 2005 (70 FR 15574). The error resulted in an incorrect AD number. This AD applies to certain British Aerospace Model BAe 146 and Model Avro 146-RJ series airplanes. This AD requires repetitive inspections for cracking of the outer links on the main landing gear side stays, and corrective actions if necessary. This AD also provides for optional terminating action for the repetitive inspections.
Meeting of the National Center for State and Local Law Enforcement Training Advisory Committee
Document Number: 05-7481
Type: Notice
Date: 2005-04-14
Agency: Department of Homeland Security, Federal Law Enforcement Training Center
The Advisory Committee to the National Center for State and Local Law Enforcement Training (National Center) at the Federal Law Enforcement Training Center will meet on May 18, 2005, beginning at 8 a.m.
Proposal by Alpha Calcit Arizona, Limited, To Operate a Marble Mine; Coronado National Forest, Douglas Ranger District, Cochise County, AZ
Document Number: 05-7480
Type: Notice
Date: 2005-04-14
Agency: Department of Agriculture, Forest Service
The Department of Agriculture, Forest Service, hereby cancels a Notice of Intent (NOI) to prepare an environmental impact statement (EIS) for the proposed operation of a marble mine by Alpha Calcit Arizona, Limited. The NOI was published in the Federal Register on January 27, 2003 (Vol. 68, No. 17, FR 3856-3858). Preparation of this EIS is being terminated because there is presently insufficient data and information to characterize the mineral deposit in terms of quality and quantity and to sufficiently evaluate the proposed Plan of Operation.
Information Collection Activities; Extension of a Currently Approved Collection; Comment Request
Document Number: 05-7479
Type: Notice
Date: 2005-04-14
Agency: Department of the Interior, Bureau of Reclamation, Reclamation Bureau
In accordance with the Paperwork Reduction Act of 1995, this notice announces that the Bureau of Reclamation (Reclamation) intends to extend a current information collection approved by the Office of Management and Budget's (OMB). The collection is entitled Summary of Water Requirements for Crops Grown on Eligible Land, OMB No. 1006-0024. Before submitting the information collection request to the Office of Management and Budget for approval, Reclamation is soliciting comments on specific aspects of that form.
Endangered and Threatened Wildlife and Plants; Initiation of a 5-Year Review of the Florida Manatee (Trichechus manatus latirostris)
Document Number: 05-7477
Type: Notice
Date: 2005-04-14
Agency: Fish and Wildlife Service, Department of the Interior
The U.S. Fish and Wildlife Service (Service) announces a 5- year review of the Florida manatee (Trichechus manatus latirostris under section 4(c)(2)(A) of the Endangered Species Act of 1973 (Act) (16 U.S.C. 1531 et seq.). A 5-year review is conducted to ensure that the listing classification of a species is accurate. A 5-year review is based on the best scientific and commercial data available at the time of the review; therefore, we are requesting submission of any such information on the Florida manatee that has become available since its original listing as an endangered species in 1967 (32 FR 4061), under the Endangered Species Preservation Act of 1966 80 Stat. 926; 16 U.S.C. 668aa(c). The manatee (Trichechus manatus) was listed again in December, 1970 by amending Appendix A of 50 CFR 17 to include additional names to the list of foreign endangered species (35 FR 18319). Based on the results of this 5-year review, we will make the requisite determination under section 4(c)(2)(B) of the ESA.
Agency Information Collection Activities: Proposed Collection; Comments Requested
Document Number: 05-7476
Type: Notice
Date: 2005-04-14
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, Alcohol, Tobacco, Firearms, and Explosives Bureau
Contract Review Meeting
Document Number: 05-7474
Type: Notice
Date: 2005-04-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Proposed Information Collection; Comment Request; Manufacturing Extension Partnership (MEP) Program Evaluation Survey
Document Number: 05-7473
Type: Notice
Date: 2005-04-14
Agency: Department of Commerce, National Institute of Standards and Technology
The Department of Commerce (DoC), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Pub. L. 104-13 (44 U.S.C. 3506 (2)(A)).
Proposed Information Collection; Comment Request; List of Gear by Fisheries and Fishery Management Council
Document Number: 05-7472
Type: Notice
Date: 2005-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Proposed Information Collection; Comment Request; U.S. Fishermen Fishing in Russian Waters
Document Number: 05-7471
Type: Notice
Date: 2005-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Notice of Lodging Proposed Consent Decree
Document Number: 05-7465
Type: Notice
Date: 2005-04-14
Agency: Department of Justice
Milk in the Upper Midwest Marketing Area; Tentative Partial Decision on Proposed Amendments and Opportunity To File Written Exceptions to Tentative Marketing Agreement and Order
Document Number: 05-7462
Type: Proposed Rule
Date: 2005-04-14
Agency: Agricultural Marketing Service, Department of Agriculture
This tentative partial decision adopts, on an interim final and emergency basis, proposals that would amend certain features of the pooling standards and transportation credit provisions of the Upper Midwest (UMW) milk marketing order. A separate decision will be issued at a later time that will address proposals concerning the depooling and repooling of milk, temporary loss of Grade A status, and increasing the maximum administrative assessment. This decision requires determining if producers approve the issuance of the amended order on an interim basis.
Health Promotion and Disease Prevention
Document Number: 05-7460
Type: Notice
Date: 2005-04-14
Agency: Department of Health and Human Services, Indian Health Service
Injury Prevention Program Announcement Type: New
Document Number: 05-7459
Type: Notice
Date: 2005-04-14
Agency: Department of Health and Human Services, Indian Health Service
Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Document Number: 05-7458
Type: Notice
Date: 2005-04-14
Agency: Food and Drug Administration, Department of Health and Human Services
Mendocino Resource Advisory Committee
Document Number: 05-7457
Type: Notice
Date: 2005-04-14
Agency: Department of Agriculture, Forest Service
The Mendocino County Resource Advisory Committee will meet April 29, 2005, (RAC), in Willits, California. Agenda items to be covered include: (1) Approval of minutes, (2) Public comment, (3) Sub- committees (4) Discussion/Approval of projects (5) Matters before the group-discussion/action (6) Next agenda and meeting date.
Agency Information Collection Activities: New Information Collection; Comment Request
Document Number: 05-7456
Type: Notice
Date: 2005-04-14
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 05-7454
Type: Notice
Date: 2005-04-14
Agency: Federal Reserve System, Agencies and Commissions
Agency Information Collection Activities: Proposed Request and Comment Request
Document Number: 05-7451
Type: Notice
Date: 2005-04-14
Agency: Social Security Administration, Agencies and Commissions
Social Security Disability Program Demonstration Project: Benefit Offset Pilot Demonstration
Document Number: 05-7450
Type: Notice
Date: 2005-04-14
Agency: Social Security Administration, Agencies and Commissions
We announce a demonstration project relating to the Social Security disability program under title II of the Social Security Act (the Act). In this demonstration, called the Benefit Offset Pilot Demonstration, we will test modifications to current program rules that we apply to title II disability beneficiaries who work. We will also modify current rules for paying outcome payments to providers of services under the Ticket to Work and Self-Sufficiency program (Ticket to Work program). We are conducting this project under the demonstration authority provided in section 234 of the Act.
Airworthiness Directives; Cessna Model 680 Airplanes
Document Number: 05-7379
Type: Rule
Date: 2005-04-14
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for certain Cessna Model 680 airplanes. This AD requires revising the airplane flight manual (AFM) to add procedures to facilitate recovery of the cockpit display units in the event that the cockpit display units go blank, and to add flight crew briefings on the use of standby instruments in case the cockpit display units go blank and do not recover. This AD also requires repetitive tests of the avionics standard communication bus (ASCB) for any failures, and corrective action if any failure is found. This AD also requires installing hardware and avionics software upgrades; installing the upgrades will allow removal of AFM revisions and will end the repetitive inspections of the ASCB. This AD is prompted by a report indicating that analysis of the Honeywell Primus Epic systems installed on Cessna Model 680 airplanes revealed that all four of the cockpit display units could go blank simultaneously. We are issuing this AD to prevent a simultaneous loss of data from all four cockpit display units, and loss of primary navigation instruments, autopilot, flight director, master caution/ warning lights, aural warnings, global positioning system position information, and air data and altitude information to non-avionics systems. These losses could reduce the flightcrew's situational awareness, increase flightcrew workload, and consequently reduce the ability to maintain safe flight of the airplane.
Revisions to the Public Housing Operating Fund Program
Document Number: 05-7376
Type: Proposed Rule
Date: 2005-04-14
Agency: Department of Housing and Urban Development
This proposed rule would revise the regulations for the Public Housing Operating Fund Program (Operating Fund Program). Through the Operating Fund Program, HUD determines the allocation of operating subsidies to public housing agencies (PHAs). HUD developed the proposed rule with the active participation of PHAs, public housing residents, and other relevant parties using the procedures of the Negotiated Rulemaking Act of 1990. These regulatory changes reflect the recommendations made by the negotiated rulemaking committee, with some modifications, on ways to improve and clarify the current regulations governing the Operating Fund Program and take into consideration the recommendations of the congressionally-funded study by the Harvard University Graduate School of Design on the cost of operating well-run public housing.
Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Albuquerque/Bernalillo County
Document Number: 05-7336
Type: Rule
Date: 2005-04-14
Agency: Environmental Protection Agency
The EPA is approving State Implementation Plan (SIP) revisions submitted by the Governor of New Mexico on September 7, 2004. The submittal revises the second ten-year carbon monoxide (CO) maintenance plan for the Albuquerque/Bernalillo County, New Mexico area. The submittal also revises the relevant parts of the New Mexico Administrative Code (NMAC) including revisions to the General Provisions, Inspection and Maintenance (I&M) Program, and the contingency measures. We are approving these revisions in accordance with the requirements of the Federal Clean Air Act (the Act).
Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Albuquerque/Bernalillo County
Document Number: 05-7335
Type: Proposed Rule
Date: 2005-04-14
Agency: Environmental Protection Agency
The EPA is proposing to approve State Implementation Plan (SIP) revisions submitted by the Governor of New Mexico on September 7, 2004. The submittal revises the second ten-year carbon monoxide (CO) maintenance plan for the Albuquerque/Bernalillo County, New Mexico area. The submittal also revises the relevant parts of the New Mexico Administrative Code including revisions to the General Provisions, Inspection and Maintenance Program, and the contingency measures. We are proposing to approve these revisions in accordance with the requirements of the Federal Clean Air Act.
Airworthiness Directives; Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model EMB-135 and -145 Series Airplanes
Document Number: 05-7282
Type: Rule
Date: 2005-04-14
Agency: Federal Aviation Administration, Department of Transportation
The FAA is superseding an existing airworthiness directive (AD), which applies to all EMBRAER Model EMB-135 and -145 series airplanes. That AD currently requires repetitive inspections of the electrical connectors of the electric fuel pumps to detect discrepancies, and follow-on corrective actions. This new AD extends the repetitive intervals for the inspections; adds new criteria for replacing discrepant fuel pumps; adds a new requirement for applying anti-corrosion spray; adds a requirement to replace all fuel pumps with improved fuel pumps; and adds repetitive inspections after all six fuel pumps are replaced. This AD is prompted by the manufacturer's development of a new modification that addresses the unsafe condition in the existing AD. We are issuing this AD to prevent an ignition source in the fuel tank or adjacent dry bay, which could result in fire or explosion.
Air Quality Designations for the Fine Particles (PM2.5) National Ambient Air Quality Standards-Supplemental Amendments
Document Number: 05-7227
Type: Rule
Date: 2005-04-14
Agency: Environmental Protection Agency
On January 5, 2005, EPA promulgated air quality designations for all areas for the national ambient air quality standards (NAAQS) for fine particles (i.e. particles less than 2.5 microns in diameter, also known as PM2.5) (70 FR 944). We designated 47 areas composed of 224 counties and the District of Columbia as nonattainment. We designated 5 areas comprised of 7 counties as unclassifiable. We designated the remaining counties in the United States as attainment/ unclassifiable. We based the designations in the January 5, 2005, final rule on air quality monitoring data from the 3-year period of 2001 to 2003. In that action, we provided that these designations would be effective 90 days from the date of publication in the Federal Register, which is April 5, 2005. Because the designations occurred at the end of 2004, we indicated our desire to consider 2004 data where feasible in order to evaluate attainment status based upon data from the 3-year period of 2002 to 2004. We explained that we would consider any complete, quality-assured, and certified 2004 PM2.5 data submitted by any State to EPA by February 22, 2005, if such data indicated that a change in the designation for the entire area would be appropriate. In the January 5, 2005, action, we stated that if EPA agreed that a change in the designation was appropriate based upon the inclusion of 2004 data, then EPA would withdraw the initial designation for the area and issue a designation that reflected the consideration of the new data before the April 5, 2005, effective date. Today's action addresses areas for which States have submitted complete, quality-assured, and certified PM2.5 air quality data for 2004, and it modifies the designation status to attainment for eight areas we originally designated as nonattainment and for four areas we originally designated as unclassifiable. This action also includes technical corrections related to boundary descriptions for a few areas included in the January 5, 2005, action. The EPA has received a number of other petitions in connection with the PM2.5 designations pertaining to issues other than inclusion of 2004 data as a basis for changing the designation prior to the effective date. The EPA is not responding to those petitions in this document and will be evaluating and responding to those petitions separately.
Classification of Certain Foreign Entities
Document Number: 05-6855
Type: Proposed Rule
Date: 2005-04-14
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This issue of the Federal Register contains temporary and final regulations relating to certain business entities included on the list of foreign business entities that are always classified as corporations for Federal tax purposes. The text of those temporary regulations also serves as the text of these proposed regulations. This document also provides a notice of a public hearing on these proposed regulations.
Withholding Exemptions
Document Number: 05-6719
Type: Proposed Rule
Date: 2005-04-14
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing temporary regulations providing guidance under section 3402(f) of the Internal Revenue Code (Code) for employers and employees relating to the Form W-4, ``Employee's Withholding Allowance Certificate.'' The temporary regulations provide rules for the submission of copies of certain withholding exemption certificates to the IRS, the notification provided to the employer and the employee of the maximum number of withholding exemptions permitted, and the use of substitute forms. The text of the temporary regulations also serves as the text of these proposed regulations. This document also provides notice of a public hearing on these proposed regulations.
Withholding Exemptions
Document Number: 05-6718
Type: Rule
Date: 2005-04-14
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains regulations providing guidance under section 3402(f) of the Internal Revenue Code (Code) for employers and employees relating to the Form W-4, ``Employee's Withholding Allowance Certificate.'' These regulations provide rules for the submission of copies of certain withholding exemption certificates to the IRS, the notification provided to the employer and the employee of the maximum number of withholding exemptions permitted, and the use of substitute forms. The text of the temporary regulations also serves as the text of the proposed regulations set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section in this issue of the Federal Register. The amendments to the final regulations provide cross-references to the temporary regulations.
Classification of Certain Foreign Entities
Document Number: 05-6716
Type: Rule
Date: 2005-04-14
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains temporary and final regulations relating to certain business entities included on the list of foreign business entities that are always classified as corporations for Federal tax purposes. The text of the temporary regulations also serves as the text of the proposed regulations set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section in this issue of the Federal Register.
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