November 24, 2014 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 122
Medicare Program; Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Technical Amendment
Document Number: 2014-27737
Type: Rule
Date: 2014-11-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This technical amendment corrects codification, terminology, and technical errors in the requirements for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) at 42 CFR 424.57.
Reserve Forces Policy Board; Notice of Federal Advisory Committee Meeting
Document Number: 2014-27736
Type: Notice
Date: 2014-11-24
Agency: Department of Defense, Office of the Secretary
The Department of Defense is publishing this notice to announce that the following Federal Advisory Committee meeting of the Reserve Forces Policy Board (RFPB) will take place.
Notice of Meeting of the Industry Trade Advisory Committee on Small and Minority Business (ITAC-11)
Document Number: 2014-27735
Type: Notice
Date: 2014-11-24
Agency: Office of the United States Trade Representative
The Industry Trade Advisory Committee on Small and Minority Business (ITAC-11) will hold a meeting on Monday, December 8, 2014. The meeting will be open to the public from 1:00 p.m. to 3:30 p.m.
True Ultimate Standards Everywhere, Inc., Doing Business as TRUSTe, Inc.; Analysis To Aid Public Comment
Document Number: 2014-27733
Type: Notice
Date: 2014-11-24
Agency: Federal Trade Commission, Agencies and Commissions
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. 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.
New Clinical Trials Demographic Data; Availability for Comment
Document Number: 2014-27732
Type: Notice
Date: 2014-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for public comment of Demographic Subgroup Data for FDA Approved Products on FDA's Internet Web site. This new posting implements Action 3.1 from Priority 3 of the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan designed to improve the availability and transparency of clinical trial demographic subgroup data. FDA is requesting comments on the format, content, and overall usability of the site to determine whether this approach is user friendly to the public.
Proposed Information Collection; Comment Request; Coral Reef Conservation Program Survey
Document Number: 2014-27731
Type: Notice
Date: 2014-11-24
Agency: Department of Commerce
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.
Agency Information Collection Activities: Application for Waiver of Grounds of Excludability, Form I-690; Revision of a Currently Approved Collection
Document Number: 2014-27730
Type: Notice
Date: 2014-11-24
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on September 19, 2014, at 79 FR 56384, allowing for a 60-day public comment period. USCIS received a comment in connection with the 60-day notice.
Intent To Prepare a Draft Environmental Impact Statement for the Proposed He'eia National Estuarine Research Reserve in Kane'ohe Bay, Hawai'i
Document Number: 2014-27729
Type: Notice
Date: 2014-11-24
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
In accordance with section 315 of the Coastal Zone Management Act of 1972, as amended (16 U.S.C. 1451-1466), the State of Hawai`i and the National Oceanic and Atmospheric Administration (NOAA) intend to conduct two public scoping meetings on December 17, 2014, in Kane`ohe, Hawai`i, and on December 19, 2014, in Honolulu, Hawai`i, as part of NOAA's draft environmental impact statement (DEIS) and draft management plan (DMP) process to solicit comments for the preparation of a DEIS and DMP on the Proposed He'eia National Estuarine Research Reserve in Kane'ohe Bay.
Agency Information Collection Activities: Application for Permission To Reapply for Admission Into the United States After Deportation or Removal, Form I-212; Revision of a Currently Approved Collection
Document Number: 2014-27728
Type: Notice
Date: 2014-11-24
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on July 16, 2014, at 79 FR 41585, allowing for a 60-day public comment period. USCIS did receive a comment in connection with the 60-day notice.
Agency Information Collection Activities: Application for Asylum and for Withholding for Removal, Form I-589; Extension, Without Change, of a Currently Approved Collection
Document Number: 2014-27727
Type: Notice
Date: 2014-11-24
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on August 21, 2014, at 79 FR 49527, allowing for a 60-day public comment period. USCIS did receive two comments in connection with the 60-day notice.
Agency Information Collection Activities: Application for Suspension of Deportation or Special Rule Cancellation of Removal (Pursuant to Section 203 of Public Law 105-100, NACARA), Form I-881; Extension, Without Change, of a Currently Approved Collection
Document Number: 2014-27725
Type: Notice
Date: 2014-11-24
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on August 21, 2014, at 79 FR 49529, allowing for a 60-day public comment period. USCIS did receive two comments in connection with the 60-day notice.
Proposed Collection; Comment Request for Form 928
Document Number: 2014-27724
Type: Notice
Date: 2014-11-24
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 928, Fuel Bond.
Intent To Prepare a Draft Environmental Impact Statement for the Sabine Pass to Galveston Bay, TX, Coastal Storm Risk Management and Ecosystem Restoration Feasibility Study
Document Number: 2014-27723
Type: Notice
Date: 2014-11-24
Agency: Department of Defense, Department of the Army, Corps of Engineers
The Sabine Pass to Galveston Bay, Texas, study area encompasses six coastal counties on the upper Texas Gulf coastOrange, Jefferson, Chambers, Harris, Galveston and Brazoria. The Draft Integrated Feasibility Report and Environmental Impact Statement (DIFR- EIS) will evaluate structural and non-structural alternatives which address coastal storm risk management (CSRM) and ecosystem restoration (ER) impacts in the study area. The environmental impact study will focus on environmental and social conditions currently present and those likely to be affected by potential future impacts of storm surge and ecosystem restoration opportunities. Several major historical surge events have occurred in the study area in the past 120 years. The most notable is perhaps the 1900 Storm, which inundated most of the island city of Galveston, TX, and adjacent areas on the mainland. The storm was responsible for over eight thousand deaths and up to $30 million in property damage. Hurricane Rita in 2005 resulted in storm surge of 9.2 feet in Port Arthur, TX, and just over 8 feet in Sabine Pass. Most recently, Hurricane Ike in 2008 produced storm surges of 14 feet near Sabine Pass and 11 to 12 feet across Sabine Lake. The City of Port Arthur was spared from the impacts of storm surge thanks to its existing 14- to 17-foot hurricane flood protection system. However, the remaining southern half of Jefferson County was inundated, with estimated high water marks reaching 18 to19 feet to the south and east of High Island. The City of Galveston was protected from Hurricane Ike's high energy surge impacts by the Galveston Seawall, but much of the City of Galveston was later flooded by about 6 to 10 feet of surge coming from the bay. The City of Texas City was protected from Ike's surge impacts by its existing hurricane flood protection system. At risk within the study area are approximately 2.26 million people living within the storm-surge inundation zone, three of the nine largest oil refineries in the world, 40 percent of the nation's petrochemical industry, 25 percent of the nation's petroleum-refining capacity, and three of the ten largest U.S. seaports.
Agency Information Collection Activities; Submission for OMB Review; Comment Request
Document Number: 2014-27721
Type: Notice
Date: 2014-11-24
Agency: Federal Trade Commission, Agencies and Commissions
In compliance with the Paperwork Reduction Act (PRA) of 1995, the FTC is seeking public comments on its request to OMB for a three- year extension of the Trade Regulation Rule entitled Labeling and Advertising of Home Insulation (R-value Rule or Rule). That clearance expires on December 31, 2014.
Agency Information Collection Activities; Company-Run Annual Stress Test Reporting Template and Documentation for Covered Institutions With Total Consolidated Assets of $10 Billion to $50 Billion Under the Dodd-Frank Wall Street Reform and Consumer Protection Act
Document Number: 2014-27720
Type: Notice
Date: 2014-11-24
Agency: Department of the Treasury
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on this continuing information collection, as required by the Paperwork Reduction Act of 1995. Under the Paperwork Reduction Act, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment on proposed revisions to the regulatory reporting templates and documentation for covered institutions with total consolidated assets of $10 billion to $50 billion.
Council Pre-Award Notification Requirements for Grants Agreements
Document Number: 2014-27719
Type: Notice
Date: 2014-11-24
This notice constitutes a compilation of the Council's pre- award requirements for grants and cooperative agreements, including all amendments and revisions to date.
Notice of Solicitation of Applications for Stakeholder Representative Members of the Missouri River Recovery Implementation Committee
Document Number: 2014-27718
Type: Notice
Date: 2014-11-24
Agency: Department of Defense, United States Army Corps of Engineers
The Commander of the Northwestern Division of the U.S. Army Corps of Engineers (Corps) is soliciting applications to fill vacant stakeholder representative member positions on the Missouri River Recovery Implementation Committee (MRRIC). Members are sought to fill vacancies on a committee to represent various categories of interests within the Missouri River basin. The MRRIC was formed to advise the Corps on a study of the Missouri River and its tributaries and to provide guidance to the Corps with respect to the Missouri River recovery and mitigation activities currently underway. The Corps established the MRRIC as required by the U.S. Congress through the Water Resources Development Act of 2007 (WRDA), Section 5018.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Previously Approved Collection; COPS Application Package
Document Number: 2014-27717
Type: Notice
Date: 2014-11-24
Agency: Department of Justice
The Department of Justice (DOJ), Community Oriented Policing Services (COPS) Office, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Notice of Centennial Challenges Cube Quest Challenge
Document Number: 2014-27714
Type: Notice
Date: 2014-11-24
Agency: National Aeronautics and Space Administration, Agencies and Commissions
This notice is issued in accordance with 51 U.S.C. 20144(c). The Cube Quest (CQ) Challenge is scheduled and teams that wish to compete may now register. Centennial Challenges is a program of prize competitions to stimulate innovation in technologies of interest and value to NASA and the nation. The Cube Quest Challenge is a prize competition designed to encourage development of new technologies or application of existing technologies in unique ways to advance cubsat communication and propulsion systems. NASA is providing the prize purse.
Framework for Regulatory Oversight of Laboratory Developed Tests; Public Workshop; Request for Comments
Document Number: 2014-27713
Type: Notice
Date: 2014-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
Guidelines for Evaluating the Effects of Light-Water Reactor Coolant Environments in Fatigue Analyses of Metal Components
Document Number: 2014-27712
Type: Notice
Date: 2014-11-24
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1309, ``Guidelines for Evaluating the Effects of Light-Water Reactor Coolant Environments in Fatigue Analyses of Metal Components.'' This guide, Revision 1 of Regulatory Guide 1.207 has been revised to consolidate, update, and replace previous NRC staff guidance on the effects of light-water reactor coolant environments on the fatigue lives of nuclear power plant components. This proposed revision provides an alternative to previous guidance provided for new reactors in Revision 0 of this guide, as well as to previous guidance provided for license renewal of operating reactors in the Generic Aging Lessons Learned (GALL) Report and the Standard Review Plan for License Renewal (SRP-LR). This guide supports reviews of applications for new nuclear reactor construction that are licensed under the NRC's regulations.
TPG Specialty Lending, Inc., et al.; Notice of Application
Document Number: 2014-27696
Type: Notice
Date: 2014-11-24
Agency: Securities and Exchange Commission, Agencies and Commissions
Summary of Application: Applicants request an order to permit a business development company (``BDC'') to co-invest in portfolio companies with affiliated investment funds.
Proposed Collection; Comment Request
Document Number: 2014-27695
Type: Notice
Date: 2014-11-24
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2014-27694
Type: Notice
Date: 2014-11-24
Agency: Securities and Exchange Commission, Agencies and Commissions
Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Final Guidance for Industry; Availability
Document Number: 2014-27693
Type: Notice
Date: 2014-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.'' The guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The guidance is intended to assist human drug compounders that elect to register as outsourcing facilities in registering, re-registering, or de-registering with FDA. The guidance provides information on how an outsourcing facility should submit facility registration information electronically in structured product labeling (SPL) format using FDA's electronic submission system. This guidance reflects the Agency's current thinking on the issues addressed by the guidance.
Fees for Human Drug Compounding Outsourcing Facilities Under the FD&C Act; Guidance for Industry; Availability
Document Number: 2014-27692
Type: Notice
Date: 2014-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.'' The guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA). Entities that elect to register as outsourcing facilities must pay certain fees to be considered outsourcing facilities. This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee.
Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft Guidance
Document Number: 2014-27691
Type: Notice
Date: 2014-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled ``Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The revised draft guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug compounders that choose to register as outsourcing facilities. Such compounders must report information on the drugs they have compounded in Structured Product Labeling (SPL) format using FDA's electronic submissions system. This revised draft guidance supersedes a draft guidance entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.''
Mark Barr v. Ocean Trade Lines, Inc.; Notice of Filing of Complaint and Assignment
Document Number: 2014-27690
Type: Notice
Date: 2014-11-24
Agency: Federal Maritime Commission, Agencies and Commissions
The Critical Infrastructure Partnership Advisory Council
Document Number: 2014-27689
Type: Notice
Date: 2014-11-24
Agency: Department of Homeland Security
The Department of Homeland Security (DHS) announced the establishment of the Critical Infrastructure Partnership Advisory Council (CIPAC) in a Federal Register Notice (71 FR 14930-14933) dated March 24, 2006, which identified the purpose of CIPAC, as well as its membership. This notice provides: (i) Quarterly CIPAC membership updates; (ii) instructions on how the public can obtain the CIPAC membership roster and other information on the council; and (iii) information on recently completed CIPAC meetings.
Information Collection Activities
Document Number: 2014-27688
Type: Notice
Date: 2014-11-24
Agency: Pipeline and Hazardous Materials Safety Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995, PHMSA invites comments on certain information collections pertaining to hazardous materials transportation for which PHMSA intends to request renewal from the Office of Management and Budget (OMB).
Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Electronic Operations
Document Number: 2014-27686
Type: Notice
Date: 2014-11-24
Agency: Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury
The OCC, 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 a continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning renewal of its information collection titled, ``Electronic Operations.'' The OCC is also giving notice that it has sent the collection to OMB for review.
Magnesium Metal From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2013-2014
Document Number: 2014-27685
Type: Notice
Date: 2014-11-24
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (``Department'') is conducting the administrative review of the antidumping duty order on magnesium metal from the People's Republic of China (``PRC''). The period of review (``POR'') is April 1, 2013, through March 31, 2014. This review covers two PRC companies, Tianjin Magnesium International, Co., Ltd. (``TMI'') and Tianjin Magnesium Metal, Co., Ltd. (``TMM''). The Department preliminarily finds that TMI and TMM did not have reviewable entries during the POR. We invite interested parties to comment on these preliminary results.
Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Metastatic Melanoma
Document Number: 2014-27680
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to the current licensee, Lion Biotechnologies, Inc., which is located in Woodland Hills, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications:
Findings of Failure To Submit a Complete State Implementation Plan for Section 110(a) Pertaining to the 2010 Nitrogen Oxide (NO2
Document Number: 2014-27679
Type: Rule
Date: 2014-11-24
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking final action finding that the District of Columbia and seven states (Alaska, Arkansas, Hawaii, Minnesota, New Jersey, Vermont and Washington) have not submitted complete infrastructure State Implementation Plans (SIPs) that provide the basic Clean Air Act (CAA) program elements necessary to implement the 2010 nitrogen dioxide (NO2) primary national ambient air quality standard (NAAQS). Three out of the seven states (Alaska, Arkansas and Vermont) have not made any submittals. The District of Columbia and the remaining four out of the seven states (Hawaii, Minnesota, New Jersey and Washington) have made submittals that are partially incomplete due to the lack of complete SIP approved Prevention of Significant Deterioration (PSD) permit programs. The purpose of an infrastructure SIP submission is to assure that a state, local or tribal air agency's SIP contains the necessary structural requirements for any new or revised NAAQS. The remaining 43 states have made complete submissions. Each finding of failure to submit a complete infrastructure SIP establishes a 24-month deadline for the EPA to promulgate a Federal Implementation Plan (FIP) to address the outstanding SIP elements unless, prior to the EPA promulgating a FIP, the affected air agency submits, and the EPA approves, a revised SIP that corrects the deficiency. In those areas without a state-adopted PSD permit program, the FIP obligation has already been met through federal regulations that govern PSD permits issued in some cases by the EPA and in other cases by state or local agencies under delegation agreements.
Request for Comment on Draft Vaccines Adverse Event Reporting System (VAERS) 2.0 Form
Document Number: 2014-27678
Type: Notice
Date: 2014-11-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is publishing this notice requesting public comment on the proposed VAERS 2.0 form, which is intended to replace the current VAERS-1 form (https:// vaers.hhs.gov/resources/vaers_form.pdf). CDC and the U.S. Food and Drug Administration (FDA) co-administer the Vaccines Adverse Event Reporting System (VAERS), a post-licensure (i.e., after vaccines have been licensed by the FDA and are being used in the community) reporting system that accepts submitted reports of adverse events that occur after vaccination from healthcare providers, manufacturers, and the public. Healthcare providers and vaccine manufacturers are required to submit VAERS reports. The National Childhood Vaccine Injury Act of 1986, section 2125 of the Public Health Service Act (42 U.S.C. 300aa- 25) authorized VAERS. The current VAERS form has been used since 1990.