August 22, 2008 – Federal Register Recent Federal Regulation Documents

Results 101 - 133 of 133
Prospective Grant of an Exclusive License: Diagnostics Based on Immune Reactions to Brother of the Regulator of Imprinted Sites (BORIS)
Document Number: E8-19454
Type: Notice
Date: 2008-08-22
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in PCT Application No. PCT/US2007/77281, entitled ``BORIS Isoforms and Methods of Detecting and Treating Disease'' filed August 30, 2007 (E-117-2006/0-PCT-02); EP Application No. 05799643.1, entitled ``Method of Detecting Cancer Based On Immune Reaction To BORIS'' filed September 21, 2005 (E-241-2004/0-EP-03); U.S. Application Serial No. 11/575,732, entitled ``Method of Detecting Cancer Based On Immune Reaction To BORIS'' filed March 21, 2007 (E-241- 2004/0-US-04); U.S. Patent No. 7,375,206, entitled ``Brother of The Regulator of Imprinted Sites (BORIS)'' issued May 28, 2008 (E-227-2001/ 0-US-03); and EP Patent Application No. 03743179.8, entitled ``Brother of The Regulator of Imprinted Sites (BORIS)'' filed September 17, 2004 (E-227-2001/0-EP-04) to Wellstat Diagnostics, Inc. The prospective exclusive territory may be worldwide, and the field of use may be limited to manufacture and sale of diagnostics for cancer and cancer predisposition.
Proposed Collection; Comment Request; California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009 (NCI)
Document Number: E8-19453
Type: Notice
Date: 2008-08-22
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009. Type of Information Collection Request: New. Need and Use of Information Collection: The NCI has sponsored four Cancer Control Modules in the California Health Interview Survey (CHIS), and will be sponsoring a fifth to be administered in 2009. CHIS is a telephone survey that collects population-based, standardized health-related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the state. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institute, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults and subsequently in 2003 to 42,043 adults, in 2005 to 43,020 adults, and in 2007 to 48,150 adults. These adults are a representative sample of California's non-institutionalized population living in households. CHIS 2009, the fifth bi-annual survey, is planned for administration to 55,000 adult Californians. This study will allow NCI to examine patterns and trends in cancer screening and follow-up, as well as to study other cancer-related topics such as tobacco control, diet, physical activity, and obesity. Additionally, CHIS is designed to be comparable to the National Health Interview Survey (NHIS) data in order to conduct comparative analyses. CHIS provides enhanced estimates for cancer risk factors and screening among racial/ethnic minority populations. Frequency of Response: Once. Affected public: Individuals or households. Types of Respondents: U.S. adults and adolescents (persons 12 years of age and older). The total annual burden hours requested are 3,276.94 (see Table A). The annualized cost to respondents is estimated at: $55,071.88. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: E8-19450
Type: Notice
Date: 2008-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meetings
Document Number: E8-19449
Type: Notice
Date: 2008-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: E8-19448
Type: Notice
Date: 2008-08-22
Agency: Department of Health and Human Services, National Institutes of Health
Administrative Practice and Procedure; Postal Service
Document Number: E8-19446
Type: Notice
Date: 2008-08-22
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission has established formal dockets to consider three related Postal Service filings. The filings concern prices and classification changes for competitive products not of general applicability involving foreign postal administrations. The Commission's action will provide for public input and for a review to determine consistency with applicable statutory requirements.
Advisory Committee on Construction Safety and Health (ACCSH); Notice of Renewal of Charter
Document Number: E8-19444
Type: Notice
Date: 2008-08-22
Agency: Department of Labor, Occupational Safety and Health Administration
In accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended (5 U.S.C., App. 2), and its implementing regulations (41 CFR 102-3, Federal Advisory Committee Management), the Secretary of Labor has determined that the renewal of the Charter for the Advisory Committee on Construction Safety and Health (ACCSH) is necessary and in the public interest. Accordingly, the U.S. Department of Labor, Occupational Safety and Health Administration (OSHA) has renewed the ACCSH Charter with several minor revisions. The revisions relate to procedural matters which do not substantively affect the objectives or activities of the ACCSH Committee. The ACCSH Charter will expire on May 6, 2010.
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: E8-19442
Type: Notice
Date: 2008-08-22
Agency: Department of Health and Human Services, National Institutes of Health
Administrative Practice and Procedure; Postal Service
Document Number: E8-19439
Type: Notice
Date: 2008-08-22
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission has established formal dockets to consider a formal request to add a new product to the competitive product list for prices not of general applicability and incorporates a notice of execution of two related contracts. The Commission's action will provide for public input and for a review to determine consistency with applicable statutory requirements.
60-Day Notice of Intention To Request Clearance of Collection of Information; Opportunity for Public Comment
Document Number: E8-19429
Type: Notice
Date: 2008-08-22
Agency: Department of the Interior, National Park Service
Under the provisions of the Paperwork Reduction Act of 1995 and 5 CFR Part 1320, Reporting and Record Keeping Requirements, the National Park Service (NPS) invites public comments on a proposed new collection of information (1024-xxxx).
60-Day Notice of Intention To Request Clearance of Collection of Information; Opportunity for Public Comment
Document Number: E8-19427
Type: Notice
Date: 2008-08-22
Agency: Department of the Interior, National Park Service
Under the provisions of the Paperwork Reduction Act of 1995 and 5 CFR Part 1320, Reporting and Record Keeping Requirements, the National Park Service (NPS) invites public comments on a proposed new collection of information (1024-xxxx).
Fisheries of the Northeastern United States; Spiny Dogfish Fishery; Commercial Period 1 Quota Harvested
Document Number: E8-19426
Type: Rule
Date: 2008-08-22
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS announces that the spiny dogfish commercial quota available to the coastal states from Maine through Florida for the semi-annual quota period, May 1, 2008 - October 31, 2008, has been harvested. Therefore, effective 0001 hours, August 20, 2008, federally permitted spiny dofish vessels may not fish for, possess, transfer, or land spiny dogfish until November 1, 2008, when the Period 2 quota becomes available. Regulations governing the spiny dogfish fishery require publication of this notification to advise the coastal states from Maine through Florida that the quota has been harvested and to advise vessel permit holders and dealer permit holders that no Federal commercial quota is available for landing spiny dogfish in these states. This action is necessary to prevent the fishery from exceeding its Period 1 quota and to allow for effective management of this stock.
Notice of Availability of Draft Supplemental Environmental Impact Statement for the Betze Pit Expansion Project, Nevada
Document Number: E8-19396
Type: Notice
Date: 2008-08-22
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
In accordance with the National Environmental Policy Act of 1969 (NEPA, 42 U.S.C. 4321 et seq.), the Bureau of Land Management (BLM), Elko District Office has prepared a Draft Supplemental Environmental Impact Statement (DSEIS) to expand the Betze Pit at an open pit gold mine in Nevada; and by this Notice is announcing the opening of the comment period.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-19395
Type: Notice
Date: 2008-08-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Notice of Availability of Vernal Field Office Proposed Resource Management Plan and Final Environmental Impact Statement (PRMP/FEIS)
Document Number: E8-19394
Type: Notice
Date: 2008-08-22
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
In accordance with the National Environmental Policy Act of 1969 and the Federal Land Policy and Management Act of 1976, the Bureau of Land Management (BLM) has prepared a Proposed Resource Management Plan/Final Environmental Impact Statement (PRMP/FEIS) for the Vernal Field Office.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-19393
Type: Notice
Date: 2008-08-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Airworthiness Directives; Pratt & Whitney Canada (P&WC) JT15D-5; -5B; -5F; and -5R Turbofan Engines
Document Number: E8-19390
Type: Proposed Rule
Date: 2008-08-22
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as follows:
Notice of Availability of the Kemmerer Proposed Resource Management Plan and Final Environmental Impact Statement, Wyoming
Document Number: E8-19387
Type: Notice
Date: 2008-08-22
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
In accordance with the National Environmental Policy Act of 1969 and the Federal Land Policy and Management Act of 1976, the Bureau of Land Management (BLM) with its cooperating agencies has prepared a Proposed Resource Management Plan/Final Environmental Impact Statement (PRMP/FEIS) for the Kemmerer Field Office planning area.
Over-the-Road Bus Accessibility Program Announcement of Project Selections
Document Number: E8-19358
Type: Notice
Date: 2008-08-22
Agency: Federal Transit Administration, Department of Transportation
The U.S. Department of Transportation (DOT) Federal Transit Administration (FTA) announces the selection of projects to be funded under Fiscal Year (FY) 2007 and FY 2008 appropriations for the Over- the-Road Bus (OTRB) Accessibility Program, authorized by section 3038 of the Transportation Equity Act for the 21st Century (TEA-21). The OTRB Accessibility Program makes funds available to private operators of over-the-road buses to help finance the incremental capital and training costs of complying with DOT's Over-the-Road Bus accessibility rule.
Direct Single Family Housing Loans and Grants
Document Number: E8-19350
Type: Rule
Date: 2008-08-22
Agency: Department of Agriculture, Rural Housing Service
Through this action, Rural Housing Service (RHS) is addressing the following: The Agency is revising the minimum insurance deductible amount and removing specific dollar limits with regards to insurance deductible clauses. The Agency also is clarifying the amount of dwelling coverage required to address current standards in the mortgage insurance industry and the coverage that the Agency may obtain when force-placed insurance is required. The intended effect is to make it easier for new homeowners to secure affordable insurance coverage and give the Agency sufficient flexibility to quickly react to changes in insurance costs and requirements. This action also is revising the applicant net asset limitation to increase it from $7,500 to $15,000 for non-elderly families and from $10,000 to $20,000 for elderly families. The intended effect is to require applicants to contribute a downpayment when their net assets exceed the stated limits. These limits have not been updated in over 10 years. Finally, this action updates the rural area definition to reference the effective date of census data collected through 2010. This rule combines three actions under one notice. In the event that we receive adverse comments on any one section of this rule, we will proceed with the final implementation of the other portions not affected. No adverse comments are anticipated.
Agency Information Collection Activities: Request for Comments for a New Information Collection
Document Number: E8-19326
Type: Notice
Date: 2008-08-22
Agency: Federal Highway Administration, Department of Transportation
The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for a new information collection, which is summarized below under Supplementary Information. We published a Federal Register Notice with a 60-day public comment period on this information collection on July 19, 2007. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.
HIPAA Administrative Simplification: Modification to Medical Data Code Set Standards To Adopt ICD-10-CM and ICD-10-PCS
Document Number: E8-19298
Type: Proposed Rule
Date: 2008-08-22
Agency: Office of the Secretary, Department of Health and Human Services
This proposed rule would modify two of the medical data code set standards adopted in the Transactions and Code Sets final rule published in the Federal Register. It would also implement certain provisions of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Specifically, the proposed rule would modify the standard code sets for coding diagnoses and inpatient hospital procedures by concurrently adopting the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, and the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding. These new codes would replace the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) Volumes 1 and 2, and the International Classification of Diseases, Ninth Revision, Clinical Modification (CM) Volume 3 for diagnosis and procedure codes, respectively.
Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards
Document Number: E8-19296
Type: Proposed Rule
Date: 2008-08-22
Agency: Department of Health and Human Services
This rule proposes to adopt updated versions of the standards for electronic transactions originally adopted in the regulations entitled, ``Health Insurance Reform: Standards for Electronic Transactions,'' published in the Federal Register on August 17, 2000, which implemented some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These standards were modified in our rule entitled, ``Health Insurance Reform: Modifications to Electronic Data Transaction Standards and Code Sets,'' published in the Federal Register on February 20, 2003. This rule also proposes the adoption of a transaction standard for Medicaid Pharmacy Subrogation. In addition, this rule proposes to adopt two standards for billing retail pharmacy supplies and professional services, and to clarify who the ``senders'' and ``receivers'' are in the descriptions of certain transactions.
Proposed Class Exemption for the Provision of Investment Advice to Participants and Beneficiaries of Self-Directed Individual Account Plans and IRAs
Document Number: E8-19273
Type: Notice
Date: 2008-08-22
Agency: Employee Benefits Security Administration, Department of Labor
This document contains a notice of pendency before the Department of Labor (Department) of a proposed class exemption from certain prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974, as amended (ERISA, or the Act), and from certain taxes imposed by the Internal Revenue Code of 1986, as amended (Code). If granted, the proposed exemption would permit the provision of investment advice described in section 3(21)(A)(ii) of the Act by a fiduciary adviser to a participant or beneficiary in an individual account plan or individual retirement accounts (and certain similar plans), the acquisition, holding or sale of a security or other property pursuant to the investment advice, and the direct or indirect receipt of fees or other compensation by the fiduciary adviser (or any employee, agent, registered representative or affiliate thereof) in connection with such transactions. The proposed exemption, if granted, would affect sponsors, fiduciaries, participants and beneficiaries of participant-directed individual account plans, as well as providers of investments and investment advice-related services to such plans.
Investment Advice-Participants and Beneficiaries
Document Number: E8-19272
Type: Proposed Rule
Date: 2008-08-22
Agency: Employee Benefits Security Administration, Department of Labor
This document contains proposed regulations implementing the provisions of the statutory exemption set forth in sections 408(b)(14) and 408(g) of the Employee Retirement Income Security Act, as amended (ERISA or the Act), and parallel provisions in the Internal Revenue Code of 1986, as amended (Code), relating to the provision of investment advice described in the Act by a fiduciary adviser to participants and beneficiaries in participant-directed individual account plans, such as 401(k) plans, and beneficiaries of individual retirement accounts (and certain similar plans). Section 408(b)(14) provides an exemption from certain prohibited transaction provisions in ERISA with respect to the provision of investment advice, the investment transaction entered into pursuant to the advice, and the direct or indirect receipt of fees or other compensation by the fiduciary adviser or an affiliate in connection with the provision of advice or the transaction pursuant to the advice. Section 408(g) describes the conditions under which the investment advice-related transactions are exempt. Upon adoption, the regulations will affect sponsors, fiduciaries, participants and beneficiaries of participant- directed individual account plans, as well as providers of investment and investment advice-related services to such plans.
Federal Property Suitable as Facilities To Assist the Homeless
Document Number: E8-19212
Type: Notice
Date: 2008-08-22
Agency: Department of Housing and Urban Development
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Approval and Promulgation of Plans; North Carolina: Miscellaneous Revisions
Document Number: E8-19192
Type: Rule
Date: 2008-08-22
Agency: Environmental Protection Agency
EPA is taking direct final action to approve revisions to the State Implementation Plan (SIP) submitted by the North Carolina Department of Environment and Natural Resources (NCDENR) on behalf of the State of North Carolina on April 16, 2001, April 4, 2003, and December 14, 2004. The purpose of these revisions is to require that continuous emissions monitoring systems be used to determine compliance; specify a 24-hour block averaging time for sulfur dioxide emissions; make a correction to a cross-reference; provide options for supplying missing data and for determining heat input; and make several revisions to permit exemptions. This action is being taken pursuant to section 110 of the Clean Air Act (CAA).
Approval and Promulgation of Plans; North Carolina; Miscellaneous Revisions
Document Number: E8-19191
Type: Proposed Rule
Date: 2008-08-22
Agency: Environmental Protection Agency
EPA is proposing to approve revisions to the State Implementation Plan submitted by the North Carolina Department of Environment and Natural Resources on behalf of the State of North Carolina on April 16, 2001, April 4, 2003, and December 14, 2004. The purpose of these revisions is to require continuous emissions monitoring systems be used to determine compliance; specify a 24-hour block averaging time for sulfur dioxide emissions; make a correction to a cross-reference; provide options for supplying missing data and for determining heat input; and make several revisions to permit exemptions. This action is being taken pursuant to section 110 of the Clean Air Act. In the Final Rules Section of this Federal Register, EPA is approving the State's SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this document. Any parties interested in commenting on this document should do so at this time.
Medicare and Medicaid Programs; Application by the Accreditation Commission for Health Care for Continued Deeming Authority for Home Health Agencies
Document Number: E8-18971
Type: Notice
Date: 2008-08-22
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
This proposed notice acknowledges the receipt of a deeming application from the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act (the Act) requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare and Medicaid Programs; Announcement of Applications From Hospitals Requesting Waiver for Organ Procurement Service Area
Document Number: E8-18970
Type: Notice
Date: 2008-08-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces three hospitals' requests for a waiver from entering into an agreement with their designated Organ Procurement Organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waivers.
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