January 20, 2015 – Federal Register Recent Federal Regulation Documents
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Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.'' This draft document provides proposed guidance to industry and FDA staff about the regulation of accessories in medical devices. The guidance explains what FDA considers to be an ``accessory,'' outlines how the risk-based framework for the classification of devices applies to accessories, and describes the use of the de novo classification process for the classification of new types of accessories. This draft guidance is not final nor is it in effect at this time.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Bin Kang, Ph.D., Oklahoma Medical Research Foundation: Based on the Respondent's admission, an assessment conducted by the Oklahoma Medical Research Foundation (OMRF), and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Bin Kang, Postdoctoral Fellow, Immunobiology and Cancer Research Program, OMRF, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants AI056129 and AI104057. ORI and OMRF found that Respondent engaged in research misconduct by reporting falsified data in: ``Asb2 regulates the activity of SCF E3 ubiquitin ligases by antagonizing CAND1-mediated exchange of F-box proteins,'' submitted to Molecular Cell on June 26, 2014; hereafter referred to as the ``original Molecular Cell manuscript'' the revised version of ``Asb2 regulates the activity of SCF E3 ubiquitin ligases by antagonizing CAND1-mediated exchange of F- box proteins,'' submitted to Molecular Cell on September 29, 2014; hereafter referred to as the ``revised Molecular Cell manuscript grant application CA189216-01 submitted to the National Cancer Institute (NCI), NIH; hereafter referred to as the ``original NCI grant application'' grant application CA189216-01A1 submitted to NCI, NIH; hereafter referred to as the ``revised NCI grant application'' ORI found that Respondent knowingly falsified and/or fabricated Western blot gel images by duplication, reuse and relabeling, and/or alteration through contrast, rotation, and/or scale of the images. Specifically, Respondent included falsified images in all of the figures (Figures 1-6 and S1-5) in the original Molecular Cell manuscript, all of the figures (Figures 1-6 and S1-7) in the revised Molecular Cell manuscript, Figures 2-4, 9, and 11 in the original NCI grant application, and Figures 3-5, 10, and 11 in the revised NCI grant application. Dr. Kang has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed for a period of three (3) years, beginning on December 23, 2014: (1) To have his research supervised; Respondent agreed to ensure that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, the institution employing him must submit a plan for supervision of his duties to ORI for approval; the plan for supervision must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that he will not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon plan for supervision; (2) that any institution employing him must submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS- supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (3) to exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Declaration of Sea Area A1
The Coast Guard is declaring Sea Area A1 in certain areas off the coast of the United States based upon the performance of the Coast Guard's Rescue 21 System, and in accordance with applicable provisions of the International Convention for the Safety of Life at Sea, 1974 (SOLAS). The Coast Guard defines Sea Area A1 as those areas where more than ninety percent of the area within 20 nautical miles seaward of the territorial baseline along the East, West and Gulf Coasts of the United States, excluding Alaska, and including Hawaii, Puerto Rico, Guam, the Virgin Islands of the United States, and the Northern Mariana Islands of Saipan, Tinian, and Rota, is within coverage of Coast Guard very high frequency (VHF) Coast Stations that provide both a continuous watch for Digital Selective Calling (DSC) distress alerts on Channel 70 and a capability to respond to distress alerts.
Lower Mississippi River Waterway Safety Advisory Committee; Vacancies
The Coast Guard seeks applications for membership on the Lower Mississippi River Waterway Safety Advisory Committee. This Committee advises and makes recommendations to the Coast Guard on matters relating to safe transit of vessels and products to and from the ports on the Lower Mississippi River and related waterways. Applicants selected for service on the Lower Mississippi River Waterway Safety Advisory Committee via this solicitation will not begin their respective terms until August 27, 2015.
Procedures for Requesting Air Traffic Data under the Pilot's Bill of Rights
The FAA is taking down the ``Pilot's Bill of Rights'' hyperlink on the FAA Internet Web page (www.faa.gov/pilots) and the email address AirmenDataRequest@faa.gov for processing requests for air traffic data under the Pilot's Bill of Rights (PBR), Pub. L. 112-153 (Aug. 3, 2012). Individuals entitled to access or otherwise obtain air traffic data under the PBR should direct such requests to the FAA investigator that provided them with the written notification of investigation.
Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations
Pursuant to Section 189a. (2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued from December 25, 2014 to January 7, 2015. The last biweekly notice was published on January 6, 2015.
Notice of Open Public Hearing
Notice is hereby given of the following hearing of the U.S.- China Economic and Security Review Commission. Name: William A. Reinsch, Chairman of the U.S.-China Economic and Security Review Commission. The Commission is mandated by Congress to investigate, assess, and report to Congress annually on ``the national security implications of the economic relationship between the United States and the People's Republic of China.'' Pursuant to this mandate, the Commission will hold a public hearing in Washington, DC on January 28, 2015, ``Foreign Investment Climate in China: Present Challenges and Potential for Reform.'' Background: This is the first public hearing the Commission will hold during its 2015 report cycle to collect input from academic, industry, and government experts on national security implications of the U.S. bilateral trade and economic relationship with China. The hearing will seek to assess the most recent and pressing challenges facing foreign firms operating in China, with a spotlight on China's Anti-Monopoly Law enforcement, and the potential for China's planned reforms to create a more transparent, cooperative, and fair environment for foreign investors. The hearing will be co-chaired by Commissioners William A. Reinsch and Daniel Slane. Any interested party may file a written statement by January 28, 2015, by mailing to the contact below. A portion of each panel will include a question and answer period between the Commissioners and the witnesses. Location, Date and Time: Room: TBD. Wednesday, January 28, 2015, 8:30 a.m.3:15 p.m. Eastern Time. A detailed agenda for the hearing will be posted to the Commission's Web site at www.uscc.gov. Also, please check our Web site for possible changes to the hearing schedule. Reservations are not required to attend the hearing.
Energy Employees Occupational Illness Compensation Program Act of 2000, as Amended
The Office of Workers' Compensation Programs (OWCP) is publishing a list of Department of Energy (DOE) facilities covered under the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended (EEOICPA). This notice revises and republishes the listing of DOE facilities that was last published by OWCP on April 8, 2013 (78 FR 20950) to include additional determinations made on this subject through January 20, 2015.
60-Day Notice of Proposed Information Collection: Application for Immigrant Visa and Alien Registration
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
60-Day Notice of Proposed Information Collection: Repatriation/Emergency Medical and Dietary Assistance Loan Application
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
Wind and Water Power Program: Guidance and Application for Hydroelectric Incentive Payments
The U.S. Department of Energy (DOE) is publishing Guidance for the EPAct 2005 Section 242 Program. The guidance describes the hydroelectric incentive payment requirements and explains the type of information that owners or authorized operators of qualified hydroelectric facilities can provide DOE when applying for hydroelectric incentive payments. This incentive is available for electric energy generated and sold for a specified 10-year period as authorized under section 242 of the Energy Policy Act of 2005. In Congressional appropriations for Federal fiscal year 2014, DOE received funds to support this hydroelectric incentive program for the first time. At this time, DOE is only accepting applications from owners and authorized operators of qualified hydroelectric facilities for hydroelectricity generated and sold in calendar year 2013.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Cellulose Products Manufacturing (Renewal)
The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Cellulose Products Manufacturing (40 CFR part 63, subpart UUUU) (Renewal)'' (EPA ICR No. 1974.07, OMB Control No. 2060-0488) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of the ICR, which is currently approved through January 31, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor, and a person is not required to respond, to a collection of information unless it displays a currently valid OMB control number.
Approval and Promulgation of Implementation Plans; North Carolina; Inspection and Maintenance Program Updates
Due to the receipt of adverse comments, the Environmental Protection Agency (EPA) is withdrawing the November 20, 2014, direct final rule to approve North Carolina's January 31, 2008, May 24, 2010, October 11, 2013, and February 11, 2014, State Implementation Plan (SIP) submissions pertaining to changes to the North Carolina Inspection and Maintenance (I/M) program. EPA will address the adverse comments in a subsequent final action based on the parallel proposal also published on November 20, 2014. As stated in the proposal, EPA will not institute a second comment period on this action.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Bulk Gasoline Terminals (Renewal)
The Environmental Protection Agency has submitted an information collection request (ICR), ``NSPS for Bulk Gasoline Terminals (40 CFR part 60, subpart XX) (Renewal)'' (EPA ICR No. 0664.11, OMB Control No. 2060-0006) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through January 31, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Leather Finishing Operations (Renewal)
The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Leather Finishing Operations (40 CFR part 63, subpart TTTT) (Renewal)'' (EPA ICR No. 1985.06, OMB Control No. 2060-0478) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through January 1, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Application for Reimbursement to Local Governments for Emergency Response to Hazardous Substance Releases Under CERCLA, Section 123 (Renewal)
The Environmental Protection Agency has submitted an information collection request (ICR), ``Application for Reimbursement to Local Governments for Emergency Response to Hazardous Substance Releases Under CERCLA, section 123 (Renewal)'' (EPA ICR No. 1425.10, OMB Control No. 2050-0077) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through January 31, 2015. Public comments were previously requested via the Federal Register (79 FR 45189) on Aug 4, 2014, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Fisheries of the South Atlantic and the Gulf of Mexico; Southeast Data, Assessment and Review (SEDAR); Public Meetings
The SEDAR 39 assessment of the HMS Smoothhound Sharks: a Data Workshop; a series of Assessment webinars; and a Review Workshop.
New England Fishery Management Council; Public Meeting
The New England Fishery Management Council's (Council) Risk Policy Working Group will meet to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).
General Wellness: Policy for Low Risk Devices; 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 ``General Wellness: Policy for Low Risk Devices.'' FDA is issuing this draft guidance to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health's (CDRH's) compliance policy for low risk products that promote a healthy lifestyle (general wellness products). This draft guidance is not final nor is it in effect at this time.
Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; 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 ``Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.'' FDA has received reports of blood and stool traveling through colonoscope irrigation channels and into the water bottle and tubing when the irrigation channel did not have a backflow-prevention mechanism in place. This draft guidance document, when finalized, will highlight the cross- contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes, clarify terminology used to describe these devices, and outline strategies to mitigate the risk of cross-contamination between patients. This draft guidance is not final nor is it in effect at this time.
Petition for Exemption; Summary of Petition Received
This notice contains a summary of a petition seeking relief from specified requirements of Title 14, Code of Federal Regulations (14 CFR). The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Petition for Exemption; Summary of Petition Received
This notice contains a summary of a petition seeking relief from specified requirements of Title 14, Code of Federal Regulations (14 CFR). The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Petition for Exemption; Summary of Petition Received; Sterling Aviation
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Aviation Rulemaking Advisory Committee-New Task
The FAA assigned the Aviation Rulemaking Advisory Committee (ARAC) a continuation of task to a previously established working group. This continuation of task requests the working group to provide cost and benefit data for the proposed implementation of the ARAC recommendations submitted in 2012 regarding the FAA's approach to update, reorganize and improve the level of safety requirements for the flammability of materials for transport category airplanes. This notice informs the public of a continuation to a previous ARAC activity, reinstates the Materials Flammability Working Group, and does not solicit membership.
Petition for Exemption; Summary of Petition Received
This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Petition for Exemption; Summary of Petition Received; Freight Runners Express
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Petition for Exemption; Summary of Petition Received; Freight Runners Express
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Bruneau-Owyhee Sage-Grouse Habitat Project, Owyhee County, Idaho
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Boise District, Boise, Idaho, intends to prepare an Environmental Impact Statement (EIS) and by this notice is announcing the beginning of the scoping process to solicit public comments to identify relevant issues.
Franchise Agreement Reviews, Affiliation and Eligibility for Financial Assistance
On December 8, 2014, the U.S. Small Business Administration (SBA) published a notice in the Federal Register to solicit public comments on, among other things, the factors relevant to determining affiliation between entities involved in a franchise or similar business relationship and also on the current processes for making such determinations. This notice announces the extension of the current comment period for an additional 60 days until April 7, 2015.
Agency Information Collection Activities: Proposed Collection; Submission for OMB Review
In accordance with the Paperwork Reduction Act (PRA), the Equal Employment Opportunity Commission (EEOC or Commission) hereby gives notice that it has submitted to the Office of Management and Budget (OMB) a request for a three-year extension with change of the Local Union Report (EEO-3). The EEOC is proposing revisions to the race and ethnicity categories on the EEO-3 report to conform to OMB's Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity (October 30, 1997) (Revised Standards), as applied in OMB Bulletin No. 00-02, Guidance on Aggregation and Allocation of Data on Race for Use in Civil Rights Monitoring and Enforcement (March 9, 2000).
Agency Information Collection Activities: Proposed Collection; Submission for OMB Review
In accordance with the Paperwork Reduction Act (PRA), the Equal Employment Opportunity Commission (EEOC or Commission) hereby gives notice that it has submitted to the Office of Management and Budget (OMB) a request for a three-year extension with change of the State and Local Government Information Report (EEO-4). The EEOC is proposing revisions to the race and ethnicity categories on the EEO-4 report to conform to OMB's Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity (October 30, 1997) (Revised Standards), as applied in OMB Bulletin No. 00-02, Guidance on Aggregation and Allocation of Data on Race for Use in Civil Rights Monitoring and Enforcement (March 9, 2000).
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