March 22, 2010 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 143
Impact of Dissolvable Tobacco Use on Public Health; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket to provide an opportunity for interested parties to share information, research, and ideas on how use of dissolvable tobacco products may impact public health, including such use among children. This information will be used to support the work of the Tobacco Products Scientific Advisory Committee, which is charged with evaluating this issue.
U.S. Air Force Scientific Advisory Board Notice of Meeting
Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces that the United States Air Force Scientific Advisory Board (SAB) meeting will take place on Tuesday, April 13th, 2010, at the 11th Air Force Headquarters Building, 10480 22d Street, Elmendorf Air Force Base, Alaska, 99506. The meeting will be from 8 a.m.-12:15 p.m.
Privacy Act of 1974; System of Records
Pursuant to the Privacy Act of 1974, 5 U.S.C. 552a, the Justice Management Division, Department of Justice, proposes to modify the Accounting Systems for the Department of Justice, Justice/DOJ-001, to update the ``Record Source Categories'' section of the notice. The full text of this System of Records Notice was last published at 69 FR 31406, June 3, 2004.
Compliance Policy Guide Sec. 540.375 Canned Salmon - Adulteration Involving Decomposition (CPG 7108.10); Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide Sec. 540.375 Canned Salmon Adulteration Involving Decomposition (CPG 7108.10) (CPG Sec. 540.375). CPG Sec. 540.375 is included in FDA's Compliance Policy Guides Manual, which was listed in the Annual Comprehensive List of Guidance Documents that published on March 28, 2006.
Workforce Investment Act; Native American Employment and Training Council
Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (FACA) (Pub. L. 92-463), as amended, and Section 166(h)(4) of the Workforce Investment Act (WIA) [29 U.S.C. 2911(h)(4)], notice is hereby given of the next meeting of the Native American Employment and Training Council (Council), as constituted under WIA.
Labor Surplus Area Classification Under Executive Orders 12073 and 10582
The Department of Labor Employment and Training Administration published a notice, Federal Register, Vol. 75, No. 42, Thursday, March 4, 2010, page 9955, to update the 2010 Labor Surplus Areas annual list published in the Federal Register, Vol. 74, No. 209, Friday, October 30, 2009, pages 56217-56239. This notice did not include the updated Labor Surplus Area list.
Unfair Labor Practice Proceedings
The General Counsel of the Federal Labor Relations Authority (FLRA) revises portions of its regulations regarding unfair labor practice (ULP) proceedings. The purpose of the revisions is to restore the Office of the General Counsel's (OGC) role in facilitating the resolution of disputes and in providing training and educating the FLRA's customers about their rights and responsibilities under the Federal Service Labor-Management Relations Statute (Statute). The revisions also clarify certain administrative matters relating to the filing and investigation of ULP charges. These revisions reestablish the OGC's leadership role in providing guidance on Alternative Dispute Resolution (ADR) techniques to union and agency representatives to strengthen labor-management relationships that will aid in resolving disputes short of litigation. These amended regulations are also consistent with the purposes underlying Executive Order 13522 (EO 13522) on Creating Labor-Management Forums to Improve Delivery of Government Services, issued on December 9, 2009 by President Obama. EO 13522 provides a platform from which a cooperative and productive form of labor-management relations throughout the executive branch of the Federal government will be established. The FLRA will play a prominent role in providing services, i.e., training; materials and guidances; and facilitation, which are needed to accomplish the objectives of EO 13522. With renewed attention to customer service, the OGC will use its expertise to foster successful labor-management relations through the training of union representatives and agency personnel in dispute resolution and cooperative methods of labor-management relations. Implementation of the regulatory changes will also enhance the purposes and policies of the Statute by promoting the resolution of disputes at an early stage, thereby preventing ULPs and/or reducing the need to file ULP charges, which will lower costs to the public.
Office of New Reactors; Interim Staff Guidance on Implementation of a Seismic Margin Analysis for New Reactors Based on Probabilistic Risk Assessment
The NRC is issuing its Final Interim Staff Guidance (ISG) DC/ COL-ISG-020 titled ``Implementation of a Seismic Margin Analysis for New Reactors Based on Probabilistic Risk Assessment,'' (Agencywide Documents Access and Management System (ADAMS) Accession No. ML100491233). This ISG supplements the guidance provided to the staff in Section 19.0 of NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants,'' issued March 2007 and DC/COL-ISG-03, ``Probabilistic Risk Assessment Information to Support Design Certification and Combined License Applications,'' dated June 11, 2008 (ADAMS Accession No. ML081430087) concerning the review of probabilistic risk assessment (PRA) information and severe accident assessments submitted to support design certification (DC) and combined license (COL) applications. The NRC staff intends to incorporate DC/ COL-ISG-020 into the next revision of SRP Section 19.0 and Regulatory Guide 1.206, ``Combined License Applications for Nuclear Power Plants (LWR Edition),'' June 2007.
Nominations for Members of the National Organic Standards Board
The Organic Foods Production Act (OFPA) of 1990, as amended, requires the establishment of a National Organic Standards Board (NOSB). The NOSB is a 15-member board that is responsible for developing and recommending to the Secretary a proposed National List of Allowed and Prohibited Substances. The NOSB also advises the Secretary on all other aspects of the National Organic Program. The U.S. Department of Agriculture (USDA) is requesting nominations to fill five (5) upcoming vacancies on the NOSB. The positions to be filled are: organic producer (2 positions), consumer/public interest (2 positions), and USDA accredited certifying agent (1 position). The Secretary of Agriculture will appoint a person to each position to serve a 5-year term of office that will commence on January 24, 2011, and run until January 24, 2016. USDA encourages eligible minorities, women, and persons with disabilities to apply for membership on the NOSB.
Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Salable Quantities and Allotment Percentages for the 2010-2011 Marketing Year
This rule would establish the quantity of spearmint oil produced in the Far West, by class that handlers may purchase from, or handle for, producers during the 2010-2011 marketing year, which begins on June 1, 2010. This rule invites comments on the establishment of salable quantities and allotment percentages for Class 1 (Scotch) spearmint oil of 566,962 pounds and 28 percent, respectively, and for Class 3 (Native) spearmint oil of 980,265 pounds and 43 percent, respectively. The Spearmint Oil Administrative Committee (Committee), the agency responsible for local administration of the marketing order for spearmint oil produced in the Far West, recommended these limitations for the purpose of avoiding extreme fluctuations in supplies and prices to help maintain stability in the spearmint oil market.
Airworthiness Directives; Turbomeca Arriel 2B1 Turboshaft Engines
The FAA proposes to revise an existing airworthiness directive (AD) for Turbomeca Arriel 2B1 turboshaft engines. 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: Since the issuance of AD 2007-0126 Turbom[eacute]ca has released modification TU157 which consists in modifying the pressure relief valve of the HMU by introducing a damping device into the valve. Introduction of this device has demonstrated to decrease the pressure fluctuations in the system, therefore reducing significantly the risk of wear of the delta-P diaphragm fabric. This will delete the need for a periodical replacement of the delta-P diaphragm before overhaul of the HMU. The modification TU157 is therefore considered as the terminating action for this AD.
Biocompatibles UK Ltd.; Filing of Color Additive Petition
The Food and Drug Administration (FDA) is announcing that Biocompatibles UK Ltd., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of C.I. Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6- dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9 ,10-dioxo, disodium salt] (CAS Reg. No. 4499-01-8) reacted with polyvinyl alcohol as a color additive in vascular embolization devices.
Publication of Model Notices for Health Care Continuation Coverage Provided Pursuant to the Consolidated Omnibus Budget Reconciliation Act (COBRA) and Other Health Care Continuation Coverage, as Required by the American Recovery and Reinvestment Act of 2009 (ARRA), as Further Amended by the Temporary Extension Act (TEA) of 2010, Notice
On March 2, 2010, President Obama signed the Temporary Extension Act of 2010 (Pub. L. 111-144), which extended, for a second time, and expanded the availability of the health care continuation coverage premium reduction provided for COBRA and other health care continuation coverage as required by ARRA (Pub. L. 111-5). ARRA, as amended, retained the requirement that the Secretary of Labor (the Secretary), in consultation with the Secretaries of the Treasury and Health and Human Services, develop model notices. These models are for use by group health plans and other entities that, pursuant to ARRA, as amended, must provide notices of the availability of premium reductions and additional election periods for health care continuation coverage. This document announces the availability of the model health care continuation coverage notices required by ARRA, as further amended by TEA.
Agency Information Collection Activities; Proposed Collection: Comment Request: Guidance for Industry Entitled Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with the guidance ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims,'' which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension.
Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups About Drug Products, as Used by the Food and Drug Administration
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on focus groups about drug products used by FDA to gauge informally public opinion, on a variety of subjects related to consumer, patient, or healthcare professional perceptions and use of drug products and related materials, including but not limited to, direct-to-consumer (DTC) prescription drug promotion, physician labeling of prescription drugs, Medication Guides, over-the- counter (OTC) drug labeling, emerging risk communications, patient labeling, online sales of medical products, and consumer and professional education.
Revised Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing and Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Pharmacokinetics in Patients With Impaired Renal FunctionStudy Design, Data Analysis, and Impact on Dosing and Labeling.'' The draft guidance is intended to assist sponsors planning to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug. It provides recommendations on when studies should be conducted to assess the influence of renal impairment on the pharmacokinetics of an investigational drug, the design of such studies, and how such studies should be carried out.
New Postal Product
The Commission is noticing a recently-filed Postal Service request to transfer selected Post Office Box Service locations from the Market Dominant Product List to the Competitive Product List. This
Safety Zone; Invista Inc Facility Docks, Victoria Barge Canal, Victoria, TX
The Coast Guard is establishing a safety zone for a partial blockage of the Victoria Barge Canal when the Invista Inc facility is offloading cargo from an oversized barge, which is approximately 380 feet in length. Commercial traffic will be prohibited from passing the barge while it is offloading cargo because the navigable width of the channel will be substantially reduced. The safety zone is necessary to help ensure the safety of the maritime public during these transfer operations.
Special Local Regulation, Fran Schnarr Open Water Championships, Huntington Bay, NY
This document supplements the Coast Guard's October 6, 2009 proposal to establish a permanent Special Local Regulation on the navigable waters of Huntington Bay, New York due to the annual Fran Schnarr Open Water Championships. The Special Local Regulation is required to provide for the safety of life by protecting swimmers and their safety craft from the hazards imposed by marine traffic. This supplemental notice of proposed rulemaking will reduce the size of the proposed regulated area, clarify the course description and revise the anticipated enforcement period of the special local regulation.
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