October 11, 2005 – Federal Register Recent Federal Regulation Documents
Results 51 - 96 of 96
Information Collection Available for Public Comments and Recommendations
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Maritime Administration's (MARAD's) intention to request extension of approval for three years of a currently approved information collection.
Requested Administrative Waiver of the Coastwise Trade Laws
As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.- build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket 2005-22651 at https:// dms.dot.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in Sec. 388.4 of MARAD's regulations at 46 CFR part 388.
Merchant Mariner Credentials: Temporary Procedures
On August 29, 2005, Hurricane Katrina devastated the coastlines of Louisiana, Mississippi, and Alabama. The Regional Examination Center (REC) at New Orleans, which serves 14% of mariners nation-wide including approximately 29,000 mariners in those three states, was flooded, destroying vital records and equipment, and rendering the facility temporarily inoperable. The Coast Guard is opening temporary offices in Morgan City, LA and Memphis, TN to provide services to mariners that have been affected by the closure of the REC in New Orleans.
Membership of the Office of the Secretary Performance Review Board
In accordance with 5 U.S.C. 4314(c)(4), DOC announces the appointment of persons to serve as members of the Office of the Secretary (OS) Performance Review Board (PRB). The OS/PRB is responsible for reviewing performance appraisals and ratings of Senior Executive Service (SES) members. The appointment of these members to the OS/PRB will be for a period of 24 months.
Notice of Meeting of the Advisory Committee to the National Center for State and Local Law Enforcement Training.
The Advisory Committee to the National Center for State and Local Law Enforcement Training will meet at the Embassy Suites, 500 Mall Boulevard, Brunswick, GA, on November 2, 2005, beginning at 8 a.m.
Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area
NMFS is reallocating the projected unused amount of Pacific cod from vessels using trawl and jig gear to vessels using hook-and- line and pot gear in the BSAI. These actions are necessary to allow the 2005 total allowable catch (TAC) of Pacific cod to be harvested.
Wild Horse and Burro Advisory Board; Meeting
The Bureau of Land Management (BLM) announces that the Wild Horse and Burro Advisory Board will conduct a meeting on matters pertaining to management and protection of wild, free-roaming horses and burros on the Nation's public lands.
Proposed Information Collection; Comment Request; Processed Products Family of Forms
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.
Approval and Promulgation of Implementation Plans; Texas; Speed Limits Local Measure for the Dallas/Fort Worth Ozone Nonattainment Area
The EPA is approving a State Implementation Plan (SIP) revision for the State of Texas to reduce some speed limits in the Dallas/Fort Worth (DFW) ozone nonattainment area. This measure reduces speed limits in a nine county area from 70 miles per hour to 65 miles per hour and from 65 miles per hour to 60 miles per hour. This measure was submitted on April 25, 2000, and EPA proposed approval on January 28, 2001. These speed limit reductions are designed to reduce nitrogen oxides in the DFW area as part of a strategy to aid the area in attaining of the National Ambient Air Quality Standards. The EPA is also making a technical correction to ensure that it is clear that the measure applies to a nine county area.
Office of the Under Secretary, Research, Education, and Economics; Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture Meeting
In accordance with the Federal Advisory Committee Act, 5 U.S.C. App. II, the United States Department of Agriculture announces a meeting of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21).
Privacy Act of 1974: System of Records
DOT proposes to modify an existing system of records under the Privacy Act of 1974.
Applications of Maxjet Airways, Inc. for Certificate Authority
The Department of Transportation is directing all interested persons to show cause why it should not issue an order finding MAXjet Airways, Inc., fit, willing, and able, and awarding it a certificate of public convenience and necessity to engage in interstate scheduled air transportation of persons, property and mail.
Proposed Collection: Indian Health Service Loan Repayment Program; Request for Public Comment: 30-Day Notice
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection list below. This proposed information collection project was published in the August 3, 2005, Federal Register (70 FR 44662) and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted to OMB. Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program''. Type of Information Collection Request: Extention of a currently approved collection which expires December 31, 2005. Form Number: No reporting forms required. Need and Use of Information Collection: The IHS Loan Payment Program (LRP) identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract under which the IHS agrees to repay part or all of their indebtedness for professional training education. In exchange, the health professionals agree to serve for a specified period of time in IHS health care facilities. Eligible health professionals that wish to apply must submit an application to participate in the program. The application requests personal, demographic and educational training information, including information on the educational loans of the individual for which repayment is being requested (i.e., date, amount, account number, purpose of each loan, interest rate, the current balance, etc). The data collected is needed and used to evaluate applicant eligibility; rank and prioritize applicants by specialty; assign applicants to IHS health care facilities; determine payment amounts and schedules for paying the lending institutions; and to provide data and statistics for program management review and analysis. Affected Public: Individual and households. Type of Respondents: Individuals. Table 1 below provides the following: Types of data collection instruments, estimated number of respondents, number of responses per respondent, annual number of responses, average burden hour per response, and total annual burden hour.
Proposed Information Collection: Final Rule To Implement Title V of the Tribal Self-Governance Amendments of 2000; Request for Public Comment: 30-Day Notice
The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the Act, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval. The IHS received no comments in response to the 60-day Federal Register notice (70 FR 44663) published on August 3, 2005. The purpose of this notice is to allow an additional 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0026, ``Final Rule to Implement Title V of the Tribal Self-Governance Amendments of 2000''. Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917-0026, ``Final Rule to Implement Title V of the Tribal Self-Governance Amendments of 2000''. Form Number: None. Forms: None. Need and Use of Information Collection: The ``Tribal Self-Governance Amendments of 2000'', Public Law 106-206 (the act), repeals Title III of the Indian Self-Determination Act, Public Law 93-638, as amended, (ISDA) and enacts Title V that established a permanent Self-Governance program within DHHS. Thus Indian and Alaska Native Tribes are now able to compact for the operation, control, and redesign of various IHS activities on a permanent basis. The final rule has been negotiated among representatives of Self-Governance and non-Self-Governance Tribes and the DHHS. The final rule included provision governing how DHHS/IHS carries out its responsibility to Indian Tribes under the Act and how Indian Tribes carry out their responsibilities under the Act. As required by section 517(b) of the Act, the Department has developed this final rule with active Tribal participation of Indian Tribes, inter-Tribal consortia, Tribal organizations and individual Tribal members, using the guidance of the Negotiated Rulemaking Act, 5 U.S.C. 561 et seq. Health status reporting requirements will be negotiated on an individual Tribal basis and included in individual compacts of funding agreements. Response to the data collection continues to be voluntary; however, submission of the data is essential to participation in the Tribal Self-Governance process. Self-Governance Tribes have the option of participating in the Tribal Self-Governance process. Self-Governance Tribes have the option of participating in a voluntary national uniform data collection effort with the IHS. The department is seeking continued OMB approval of the collection of information identified in the following sections of the regulations: Subpart C-Selection of Tribes for Participation in Self-Governance, Subpart D and E-Compact and Funding Agreement, Subpart N-Construction Projects, and Subpart P-Appeals. Affected Public: Individual Tribes. Type of Respondents: Tribal Representatives. The table below provides the estimated burden hours for this information collection:
Draft Guidance for Industry and FDA Staff: Compliance With the Medical Device User Fee and Modernization Act of 2002, as amended-Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amendedProminent and Conspicuous Mark of Manufacturers on Single-Use Devices.'' The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), as amended by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), requires that FDA issue guidance within 180 days of enactment (August 1, 2005) identifying the circumstances in which the name, abbreviation, or symbol identifying the manufacturer of an original device is not ``prominent and conspicuous.''
Amendment to Final Guidelines for the Coastal and Estuarine Land Conservation Program
The National Oceanic and Atmospheric Administration, National Ocean Service publishes this notice to amend the Final Guidelines for the Coastal and Estuarine Land Conservation Program (CELCP). For those grants issued in fiscal year 2002 only, CELCP may extend the financial assistance award period of grants issued in fiscal year 2002 for two additional years, totaling a maximum award duration of five years.
Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships; Exceptions for Certain Electronic Prescribing and Electronic Health Records Arrangements
As required by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), this proposed rule would create an exception to the physician self-referral prohibition in section 1877 of the Social Security Act (the Act) for certain arrangements in which a physician receives necessary non-monetary remuneration that is used solely to receive and transmit electronic prescription drug information. In addition, using our separate legal authority under section 1877(b)(4) of the Act, we are proposing two separate regulatory exceptions for electronic health records software and directly related training services. These exceptions are consistent with the President's goal of achieving widespread adoption of interoperable electronic health records for the purpose of improving the quality and efficiency of health care, while maintaining the levels of security and privacy that consumers expect.
Joint Meeting for the Southeast Oregon, John Day-Snake, and Eastern Washington Resource Advisory Councils (TRI RAC)
The TRI RAC will hold a joint meeting for all members on Monday November 7, 2005 from 8 a.m. Pacific Standard Time (PT) to 5 p.m. Tuesday November 8, 2005. The meeting will begin at 7:30 a.m. and end about noon. The meeting is being held at the Running Y Ranch Resort, Conference Room, 5500 Running Y Road, Klamath Falls, Oregon 97601. Meeting sessions are open to the public. A comment period is scheduled for 10:15 a.m. (PT) on Monday November 7, 2005. The meeting topics to be discussed include: New member orientation and video, a BLM and Forest Service update by the State Director and Regional Forester, Congressional updates, and a panel discussion on RAC involvement. Grazing regulations, the wild horse and burro program, and planning and implementation updates will follow. There will be a panel discussion on volunteerism and outside funding, stewardship contracting, proactive strategies and a RAC restructuring proposal. There may also be other issues that may come before the Councils. The Southeast Oregon Resource Advisory Council will hold a brief meeting Sunday November 6, 2005, at the Running Y Ranch Resort at 3 p.m. (PT) in the Board Room. The John Day-Snake Resource Advisory Council will hold a brief meeting on Tuesday November 8, 2005 following the close of the TRI RAC meeting. These additional meetings will be to discuss the same issues and concerns that are scheduled for the TRI RAC meeting.
Eastern Idaho Resource Advisory Committee; Caribou-Targhee National Forest, Idaho Falls, ID
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 Caribou-Targhee National Forests' Eastern Idaho Resource Advisory Committee will meet Wednesday, November 30, 2005 in Idaho Falls for a business meeting. The meeting is open to the public.
Fresno County Resource Advisory Committee
The Fresno County Resource Advisory Committee will meet in Clovis, California. The purpose of the meeting is to review funded projects, discuss 2006 project submittal process and new committee appointments regarding the Secure Rural Schools and Community Self- Determination Act of 2000 (Public Law 106-393) for expenditures of Payments to States Fresno County Title II funds.
Notice of Intent To Prepare a Comprehensive Conservation Plan and Environmental Assessment for the Handy Brake National Wildlife Refuge and the Louisiana Wetland Management District
The Fish and Wildlife Service, Southeast Region, intends to gather information necessary to prepare a comprehensive conservation plan and environmental assessment pursuant to the National Environmental Policy Act of 1969 and its implementing regulations. The National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997, requires the Service to develop a comprehensive conservation plan for each national wildlife refuge. The purpose in developing a comprehensive conservation plan is to provide refuge managers with a 15-year strategy for achieving refuge purposes and contributing toward the mission of the National Wildlife Refuge system, consistent with sound principles of fish and wildlife management, conservation, legal mandates, and Service policies. In addition to outlining broad management direction on conserving wildlife and their habitats, plans identify wildlife-dependent recreational opportunities available to the public, including opportunities for hunting, fishing, wildlife observation, wildlife photography, and environmental education and interpretation. The purpose of this notice is to achieve the following: (1) Advise other agencies and the public of our intentions, and (2) Obtain suggestions and information on the scope of issues to include in the environmental document.
Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Certain Electronic Prescribing Arrangements Under the Anti-Kickback Statute
As required by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108-173, this proposed rule would establish a new safe harbor under the Federal anti-kickback statute for certain arrangements involving the provision of electronic prescribing technology. Specifically, the safe harbor would protect certain arrangements involving hospitals, group practices, and prescription drug plan (PDP) sponsors and Medicare Advantage (MA) organizations that provide to specified recipients certain nonmonetary remuneration in the form of hardware, software, or information technology and training services necessary and used solely to receive and transmit electronic prescription drug information. In addition, using our separate legal authority under section 1128B(b)(3)(E) of the Social Security Act (the ``Act''), we are also proposing separate safe harbor protection for certain electronic health records software and directly related training services. These exceptions are consistent with the President's goal of achieving widespread adoption of interoperable electronic health records for the purpose of improving the quality and efficiency of health care, while maintaining the levels of security and privacy that consumers expect.
Aquatic Nuisance Species Task Force Meeting
This notice announces a meeting of the Aquatic Nuisance Species (ANS) Task Force. The meeting is open to the public. The meeting topics are identified in the SUPPLEMENTARY INFORMATION section.
DaVita, Inc.; Analysis of Agreement Containing Consent Orders To Aid Public Comment
The consent agreement in this matter settles alleged violations of Federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orderembodied in the consent agreementthat would settle these allegations.
Quality Systems Verification Programs
The Agricultural Marketing Service (AMS) is establishing a separate user-fee schedule for the Quality Systems Verification Programs (QSVP) and expanding the scope of the QSVP to include all agricultural products and services within the responsibility of the Livestock and Seed (LS) Program. A new part 62 is established for QSVP services. QVSP are a collection of voluntary, audit-based, user-fee programs authorized under the Agricultural Marketing Act of 1946. QSVP facilitate the global marketing and trade of agricultural products; provide consumers the opportunity to distinguish specific characteristics involved in the production and processing of agricultural products; and ensure that product consistently meets program requirements.
Seminole Electric Cooperative, Inc.; Notice of Intent To Hold Public Scoping Meeting and Prepare a Supplemental Environmental Impact Statement
The Rural Utilities Service (RUS) intends to hold a public scoping meeting and prepare a supplemental Environmental Impact Statement (EIS) in connection with possible impacts related to a project proposed by Seminole Electric Cooperative, Inc. (SECI), with headquarters in Tampa, Florida. The proposal consists of the construction of a nominal 750 megawatt coal-based electrical generating unit at the Seminole Generating Station (SGS). The Station is located in Putnam County, Florida, about six miles north of Palatka. SGS Unit 3 will be constructed near the existing SGS Units 1 and 2. The new unit can be readily accommodated on the existing site. The financing and construction of the SGS Unit 1 and 2 was evaluated in a previous EIS. SECI is requesting RUS provide financing for the proposed project.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Product Voluntary Reporting Program
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h and 2567
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h and 2567'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Fast Track Drug Development Programs-Designation, Development, and Application Review
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Fast Track Drug Development ProgramsDesignation, Development, and Application Review'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph for Over-the-Counter Nasal Decongestant Drug Products
The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies) to remove the indication ``for the temporary relief of nasal congestion associated with sinusitis'' and to prohibit use of the terms ``sinusitis'' and ``associated with sinusitis'' elsewhere on the labeling. This final rule is part of FDA's ongoing review of OTC drug products.
Exemption of Work Activity as a Basis for a Continuing Disability Review
We are proposing to amend our regulations to include rules to carry out section 221(m) of the Social Security Act (the Act). Section 221(m) affects our rules for when we will conduct a continuing disability review if you work and receive benefits under title II of the Act based on disability. (We interpret this section to include you if you receive both title II disability benefits and Supplemental Security Income (SSI) payments based on disability.) It also affects our rules on how we evaluate work activity when we decide if you have engaged in substantial gainful activity for purposes of determining whether your disability has ended. In addition, section 221(m) of the Act affects certain other standards we use when we determine whether your disability continues or ends. We are also proposing to make certain other revisions to our regulations for how we determine whether your disability continues or ends. These other proposed revisions would codify our existing operating instructions for how we consider certain work at the last two steps of our continuing disability review process. In addition, we are proposing to incorporate into our disability regulations some rules which are contained in another part of our regulations and which apply if you are using a ticket under the Ticket to Work and Self-Sufficiency program (the Ticket to Work program). Finally, we are proposing to amend our regulations to eliminate the secondary substantial gainful activity amount that we currently use to evaluate work you did as an employee before January 2001.
Alternative Market Risk and Credit Risk Capital Charges for Futures Commission Merchants and Specified Foreign Currency Forward and Inventory Capital Charges
The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is issuing this release to propose amendments to Commission rules that impose minimum financial and related reporting requirements upon each person registered as a futures commission merchant (``FCM''). Pursuant to rule amendments that became effective in August of 2004, the Securities and Exchange Commission (``SEC'') has established a method for securities brokers or dealers (``BDs'') that voluntarily elect SEC consolidated supervision for their ultimate holding companies and affiliates, and that also meet specified minimum capital and other requirements, to request approval to use internal mathematical models to determine their capital deductions for market risk and credit risk associated with their proprietary trading assets. Under the rule amendments that are proposed in this release, FCMs that are also BDs (``FCM/BDs'') would have the option, subject to the reporting and other requirements that are specified in the proposed rulemaking, of electing to compute their adjusted net capital using their SEC-approved alternative market risk and credit risk capital deductions in lieu of CFTC requirements. The Commission is also proposing other rule amendments that address confidential treatment for the reports and statements that would be required to be filed under the proposed amendments, and also to address the confidential treatment of certain other information that all FCM/BDs must file with both the Commission and the SEC. Finally, the Commission is also proposing rule amendments in this release that would amend the minimum financial requirements of FCMs and introducing brokers (``IBs'') by reducing the capital deductions for their uncovered inventory or forward contracts in specified foreign currencies. The proposed reduction is consistent with guidance currently provided by the Commission to FCMs and IBs.
Defense Federal Acquisition Regulation Supplement; Payment and Billing Instructions
DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to improve payment and billing instructions in DoD contracts. This final rule is a result of a transformation initiative undertaken by DoD to dramatically change the purpose and content of the DFARS.
HUBZone Program; Corrections
The U.S. Small Business Administration (SBA) is correcting an improper citation within the interim rule that appeared in the Federal Register on August 30, 2005, which amends SBA's HUBZone program regulations.
Energy Conservation Program for Consumer Products: Test Procedure for Residential Central Air Conditioners and Heat Pumps
The Department of Energy (DOE, or the Department) amends its test procedures for residential central air conditioners and heat pumps. This final rule adds new sections and revises several sections of the test procedure to bring it up-to-date by eliminating the need for several test procedure waivers and making it more complete. The Department also re-organized the test procedure to be more chronological in its progression. The revisions to the test procedure do not alter the minimum energy conservation standards currently in effect for central air conditioners and heat pumps.
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