November 7, 2013 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 121
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.'' This draft guidance clarifies the distinction between hearing aids and personal sound amplification products (PSAPs), as well as the regulatory controls that apply to each. This draft guidance is not final nor is it in effect at this time.
Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Design Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements.
Meeting of the National Commission on the Structure of the Air Force
The Department of Defense is publishing this notice to announce that the following Federal advisory committee closed meeting of the National Commission on the Structure of the Air Force (``the Commission'') has taken place. Due to difficulties finalizing the meeting agenda for the scheduled meeting of the National Commission on the Structure of the Air Force for November 5, 2013, this meeting notice is publishing in the Federal Register after the date of the meeting.
Intent To Conduct a Detailed Economic Impact Analysis
This notice is to inform the public that the Export-Import Bank of the United States is withdrawing a previous Federal Register notice informing the public of its intent to conduct a detailed economic impact analysis regarding a loan guarantee to support the export of U.S.-manufactured Boeing 787 wide-body passenger aircraft to an airline in China. Export-Import Bank has recently learned that the Chinese airline will not likely operate on routes in direct competition with U.S. airlines. This recent information was not available at the time the original Federal Register notice was posted on August 5th, 2013. Based on this new information, the evaluated transaction does not meet the substantial injury threshold and is therefore not subject to a detailed economic impact analysis.
Airworthiness Directives; Airbus Airplanes
We propose to supersede airworthiness directives AD 2003-14- 11, AD 2004-11-08, AD 2004-13-25, AD 2004-18-14, AD 2008-06-07, and AD 2012-04-07 that apply to certain Airbus Model A330 and A340 series airplanes. AD 2003-14-11, AD 2004-11-08, AD 2004-13-25, AD 2004-18-14, AD 2008-06-07, and AD 2012-04-07 required revising the maintenance program to incorporate certain maintenance requirements and airworthiness limitations; replacing certain flap rotary actuators; repetitively inspecting elevator servo-controllers and pressure relief valves of the spoiler servo controls (SSCs); repetitively testing the elevator servo control loops, modifying the elevator servo controls, and repetitively replacing certain retraction brackets of the main landing gear; and revising the airplane flight manual. Since we issued those ADs, we have determined that more restrictive maintenance requirements and airworthiness limitations are necessary. This proposed AD would require revising the maintenance program to incorporate certain maintenance requirements and airworthiness limitations. The proposed AD also removes Airbus Model A340-200, -300, -500, and -600 series airplanes from the applicability. We are proposing this AD to address the aging effects of aircraft systems. Such aging effects could change the characteristics leading to an increased potential for failure, which, in isolation or in combination with one or more other specific failures or events, could result in failure of certain life limited parts, which could reduce the structural integrity of the airplane or reduce the controllability of the airplane.
Subsistence Management Program for Public Lands in Alaska; Rural Determination Process
The Federal Subsistence Board is extending the comment period through December 2, 2013, on its earlier request for comments (77 FR 77005, Dec. 31, 2012) on the rural determination process. These comments will be used by the Board, coordinating with the Secretaries of the Interior and Agriculture, to assist in making decisions regarding the scope and nature of possible changes to improve the rural determination process.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 35013520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information burden for small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.
Issuance of Final Guidance Publication
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: ``Current Intelligence Bulletin 66Derivation of Immediately Dangerous to Life or Health (IDLH) Values'' [NIOSH 2014-100].
Israel Loan Guarantees Issued Under the Emergency Wartime Supplemental Appropriations Act of 2003-Standard Terms and Conditions
This regulation prescribes the revised procedures and revised standard terms and conditions applicable to loan guarantees issued for the benefit of the Government of Israel on behalf of the State of Israel. Pursuant to the Emergency Wartime Supplemental Appropriations Act of 2003, the United States of America, acting through the U.S. Agency for International Development, may issue loan guarantees applicable to sums borrowed by the Government of Israel on behalf of the State of Israel (the ``Borrower''). The loan guarantees were originally issued pursuant to a Loan Guarantee Commitment Agreement between the Borrower and the United States Government dated August 18, 2003 and applied to sums borrowed from time to time between March 1, 2003 and September 30, 2006. Pursuant to an Amended and Restated Loan Guarantee Commitment Agreement dated October 24, 2012, the loan guarantees will now apply to sums borrowed from time to time between March 1, 2003 and September 30, 2016.
Proposed Information Collection; Comment Request; Commercial Fisheries Seafood Processor Survey
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.
Certain Products Containing Interactive Program Guide and Parental Control Technology; Notice of the Commission's Final Determination Finding No Violation of Section 337; Termination of the Investigation
Notice is hereby given that the U.S. International Trade Commission has found no violation of section 337 of the Tariff Act of 1930, 19 U.S.C. 1337, in this investigation. The investigation is terminated.
Railroad Safety Technology Program Grant Program
The Railroad Safety Technology Grant Program was first authorized under the Rail Safety Improvement Act of 2008 (RSIA). The program authorizes DOT to provide grants to passenger and freight rail carriers, railroad suppliers, and State and local governments for projects that have a public benefit of improved railroad safety and efficiency. The program originally made available $50 million in Federal funds. Due to the original grantees completing their grants, $550,000 became available from the original $50 million. This grant program has a maximum 80-percent Federal and minimum 20-percent grantee cost share (cash or in-kind) match requirement.
Request for Information on the Office of Disease Prevention Draft Strategic Plan for Fiscal Years 2014-2018
The purpose of this Request for Information (RFI) is to seek broad public input on the draft Strategic Plan for Fiscal Years (FY) 2014-2018 for the Office of Disease Prevention (ODP), National Institutes of Health (NIH).
Proposed Collection; 60-Day Comment request: Gulf Long-Term Follow-Up Study (GuLF STUDY)
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 Institute of Environmental Health Sciences (NIEHS), 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. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Dale P. Sandler, Chief, Epidemiology Branch, NIEHS, Rall Building A3-05, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free number 919-541-4668 or Email your request, including your address to: Sandler@niehs.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Gulf Long-Term Follow-Up Study (GuLF STUDY), 0925-0626, Expiration Date 01/31/2014REVISION, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the GuLF STUDY is to investigate potential short- and long-term health effects associated with oil spill clean-up activities and exposures related to the Deepwater Horizon disaster, and to create a resource for additional collaborative research on focused hypotheses or subgroups. Exposures range from negligible to potentially significant; however, potential long-term human health consequences are largely unknown due to insufficient research in this area. The study has enrolled 32,762 participants with a range of jobs/ exposures, including participants who performed various types of clean- up-related work (``exposed'') and other who did not (``unexposed'' controls). Of the 32,762 enrolled into the Full Cohort, 20,000 have been assigned to the Active Follow-up Sub-cohort, and 6,000 of these have been assigned to the Biomedical Surveillance Sub-cohort. In order to minimize loss to follow-up, updated contact information will be collected yearly for the Full Cohort. Follow-up questionnaires will be administered biennially to the Active Follow-up Sub-cohort to assess changes in health status and factors that could confound associations between exposures and outcomes. A supplemental mental health questionnaire will be administered repeatedly over a 2-year period to a subset of 4,600 participants in the Active Follow-up Sub- cohort to assess mental health trajectories among those affected by the oil spill and utilization of mental health services in the Gulf region. Participants in the Biomedical Surveillance Sub-cohort will be invited to take part in a comprehensive research-based clinical examination. The clinical exam provides an opportunity to carry out more comprehensive clinical testing and mental health evaluations than could be completed during the baseline home visit. The exams will allow for a much more in-depth assessment of pulmonary, neurological, and mental health outcomes that may be associated with the Deepwater Horizon oil spill exposures and experiences. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 21,724.
Advisory Committee on Construction Safety and Health (ACCSH)
ACCSH will meet December 5-6, 2013, in Washington, DC. OSHA also announces the Assistant Secretary of Labor request for nominations for membership on ACCSH.
Prior Label Approval System: Generic Label Approval
The Food Safety and Inspection Service (FSIS) is amending the meat and poultry products inspection regulations to expand the circumstances in which FSIS will generically approve the labels of meat and poultry products. The Agency also is consolidating the regulations that provide for the approval of labels for meat products and poultry products into a new Code of Federal Regulations (CFR) part.
International Trade Administration, North American Free-Trade Agreement (NAFTA), Article 1904 Binational Panel Reviews
On October 11, 2013, the NAFTA Chapter 19 binational panel issued its decision in the review of the final results of the 2011 antidumping administrative review made by the Mexican Ministry of Economy, with respect to Certain Types of Stearic Acid from the United States, irrespective of the country of shipment (NAFTA Secretariat File Number MEX-2011-1904-01). The binational panel affirmed the Mexican Ministry of Economy's final determination regarding this matter. Copies of the panel's decision in English and Spanish are available from the U.S. Section of the NAFTA Secretariat.
Exemptions From Certain Prohibited Transaction Restrictions
This document contains exemptions issued by the Department of Labor (the Department) from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). This notice includes the following: 2013-10, UBS AG and Its Current and Future Affiliates and Subsidiaries, D-11506; 2013-11, Wells Fargo Bank, N.A., D-11640; 2013-12, Sears Holding Savings Plan, Sears Holdings Puerto Rico Savings Plan and the Lands' End, Inc. Retirement Plan, D- 11739, D-11740, and D-11741; 2013-13, American International Group, Inc. Incentive Savings Plan, American General Agents' & Managers' Thrift Plan, and Chartis Insurance Company-Puerto Rico Capital Growth Plan, D-11767, D-11768 and D-11769.
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