2014 – Federal Register Recent Federal Regulation Documents
Results 2,951 - 3,000 of 29,660
Proposed Criteria for “First Generic” Submissions for Purposes of Abbreviated New Drug Application Review Prioritization Under the Generic Drug User Fee Amendments; Establishment of a Public Docket
The Food and Drug Administration (FDA or the Agency) is announcing the opening of a public docket and requesting comments on proposed criteria for ``first generic'' abbreviated new drug application (ANDA) submissions. The purpose is to facilitate FDA's establishment of review prioritization under the Generic Drug User Fee Amendments of 2012 (GDUFA). Establishing clear criteria for this review prioritization category will allow FDA to appropriately prioritize ANDA submissions and track them in a manner consistent with the review prioritization commitments FDA made under GDUFA. Clear criteria for this category will also lead to less industry confusion and more consistent identification of ``first generic'' submissions.
Electronic Study Data Submission; Data Standards; Validation Rules for Study Data Tabulation Model Formatted Studies; Availability
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing the availability of a document entitled ``Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.'' CDER is making this document available to improve the standardization and quality of clinical data submitted to CDER, as well as to improve the predictability of data quality and usefulness.
Privacy Act of 1974; System of Records
The Defense Health Agency proposes to alter an existing system of records, EDTMA 03, entitled ``Legal Opinion Files'' in its inventory of record systems subject to the Privacy Act of 1974, as amended. This system uses records to address and resolve legal issues and for research, precedent, historical, and record purposes.
Agency Information Collection Activities; Comment Request; High School Longitudinal Study of 2009 (HSLS:09) Second Follow-Up Field Test and Main Study Panel Maintenance 2015
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.
Intent To Prepare an Environmental Impact Statement for the Snow Mountain Solar Project on the Las Vegas Paiute Indian Reservation, Clark County, Nevada
In order to comply with the National Environmental Policy Act (NEPA), the Bureau of Indian Affairs (BIA), as lead agency in cooperation with the Las Vegas Paiute Tribe (Tribe), the Bureau of Land Management (BLM), and other Federal agencies, intend to prepare an environmental impact statement (EIS) that will evaluate a proposed photovoltaic (PV) solar energy generation project on the Las Vegas Paiute Indian Reservation and a transmission line located on tribal lands, private lands and/or Federal lands administered and managed by BLM in Clark County, Nevada. This notice announces the beginning of the scoping process to solicit public comments and identify potential issues related to the EIS. It also announces that public scoping meetings will be held in Nevada to identify potential issues, alternatives, and mitigation to be considered in the EIS.
Indian Gaming
This notice publishes the Class III Gaming Compact between the Karuk Tribe and the State of California taking effect.
Gulf of Mexico Fishery Management Council; Public Meeting
The Gulf of Mexico Fishery Management Council (Council) will hold a meeting of its Coral Working Group.
Revision of Agency Information Collection for Indian Child Welfare Quarterly and Annual Report
In compliance with the Paperwork Reduction Act of 1995, the Bureau of Indian Affairs (BIA) is submitting to the Office of Management and Budget (OMB) a request for approval for the revision of collection of information for the Indian Child Welfare Quarterly and Annual Report. The information collection is currently authorized by OMB Control Number 1076-0131, which expires November 30, 2014.
President's Export Council: Meeting of the President's Export Council
The President's Export Council (Council) will hold a meeting to deliberate on recommendations related to promoting the expansion of U.S. exports and to convey a report to the President on the September 2014 fact-finding trip to Poland and Turkey by some members of the Council. Topics may include: the National Export Initiative; trade promotion authority; trade negotiations; reauthorization of the Export- Import Bank of the United States; innovation; education, skills development and workforce readiness; infrastructure; tax reform; and export control reform. The final agenda will be posted at least one week in advance of the meeting on the President's Export Council Web site at https://trade.gov/pec.
Notice of Availability and Notice of Public Meetings for the Draft Environmental Impact Statement for Central Valley Project Municipal and Industrial Water Shortage Policy, Central Valley, CA
The Bureau of Reclamation has made available for public review and comment the Central Valley Project (CVP) Municipal and Industrial Water Shortage Policy (M&I WSP) Draft Environmental Impact Statement (EIS). The Draft EIS addresses updating the CVP M&I WSP and implementation guidelines. The CVP M&I WSP would be used by Reclamation to: (1) Define water shortage terms and conditions for applicable CVP M&I water service contractors, as appropriate; (2) establish CVP water supply levels that, together with the M&I water service contractors' drought water conservation measures and other water supplies, would assist the M&I water service contractors in their efforts to protect public health and safety during severe or continuing droughts; and (3) provide information to M&I water service contractors for their use in water supply planning and development of drought contingency plans.
Commission Meeting; Correction
The Susquehanna River Basin Commission published a document in the Federal Register of November 10, 2014 (79 FR 66763), concerning its regular business meeting on December 5, 2014, in Annapolis, Maryland. The location of the meeting has been changed and the new location is contained in the Addresses section of this notice. Also an agenda item has been added to be addressed at the business meeting and is contained in the Supplementary Information section of this notice.
Request for Expressions of Interest From Manufacturers and Developers in Forthcoming Gun Safety Technology Challenge and Request for Information
The National Institute of Justice (NIJ) is requesting manufacturers and developers of firearms that incorporate advanced safety technologies or firearms accessories utilizing advanced safety technologies that are intended to modify firearms to submit an expression of interest in the forthcoming Gun Safety Technology Challenge (``Challenge'') and provide information about their products or technology. Through the Challenge, NIJ will seek an objective demonstration through testing and evaluation of the reliability of firearms and firearms accessories available today that are typically known by various terms such as smart guns, user-authorized handguns, childproof guns, and personalized firearms. These firearms or firearms accessories can be understood to utilize integrated components that exclusively permit an authorized user or set of users to operate or fire the gun and automatically deactivate it under a set of specific circumstances, reducing the chances of accidental or purposeful use by an unauthorized user. NIJ is interested in receiving information regarding which firearms and firearms accessories that incorporate advanced safety technologies that would be made available by industry for testing and evaluation in the Challenge. This information will help inform NIJ regarding the scope of the notional test methods and test procedures for firearms and firearms accessories required for the Challenge, as described below.
Criminal Justice Restraints Standard, NIJ Standard-1001.00
The National Institute of Justice (NIJ) announces publication of Criminal Justice Restraints Standard, NIJ Standard 1001.00. The document can be found here: https://ncjrs.gov/pdffiles1/nij/247988.pdf. Conformity assessment organizations are invited to review the document and provide any feedback to the point of contact listed below. This standard is planned to supersede NIJ Standard for Metallic Handcuffs, NIJ Standard 0307.01, found here: https://www.ncjrs.gov/pdffiles1/nij/ 082981.pdf. The effective date that this will occur will be given six months prior through a notice in the Federal Register. For more information about NIJ standards, please visit https://nij.gov/standards.
Privacy Act of 1974; System of Records
The Defense Health Agency proposes to alter an existing system of records, EDHA 11, entitled ``Defense Medical Human Resources System internet (DMHRSi)'' in its inventory of record systems subject to the Privacy Act of 1974, as amended. This system consolidates all of the human resources functions, including readiness, manpower, labor cost assignment, education, and training, for personnel across the DoD medical enterprise, thereby providing a single database source of instant query/access for all personnel types and the readiness posture of all DoD medical personnel. This system of records permits ready access to essential manpower, personnel, labor cost assignment, education and training, and personnel readiness information across the DoD medical enterprise.
Failure To File Gain Recognition Agreements or Satisfy Other Reporting Obligations
This document contains final and temporary regulations relating to the consequences to U.S. and foreign persons for failing to file gain recognition agreements (GRAs) or related documents, or to satisfy other reporting obligations, associated with certain transfers of property to foreign corporations in nonrecognition exchanges. The regulations are necessary to update and clarify the rules that apply when a U.S. or foreign person fails to file a GRA or related documents or to satisfy other reporting obligations. These regulations affect U.S. and foreign persons that transfer property to foreign corporations in nonrecognition exchanges.
Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978.
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act at Title 45 Part 670 of the Code of Federal Regulations. This is the required notice of permit applications received.
Prospective Grant of Exclusive License: Detection of Infectious Prion Protein by Seeded Conversion of Recombinant Prion Protein
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Amprion, Inc. located in Houston Texas, USA, to practice the inventions embodied in the following Patents and Patent Applications, each entitled ``Detection of Infectious Prion Protein by Seeded Conversion of Recombinant Prion Protein'': 1. US provisional Application 60/961,364 filed July 20, 2007 [HHS Ref. No. E-109-2007/0-US-01] 2. PCT/US2008/070656, filed July 21, 2008; [HHS Ref. No E-109-2007/ 1-PCT-01] 3. EPC application No 08796382.3 filed July 21, 2008 [HHS Ref. No E-109-2007/1-EP-03] 4. US Application No. 12/177,012, filed July 21, 2008 and issued as US patent 8,216,788 on July 10, 2012 [HHS Ref. No E-109-2007/1-US-02]; 5. US Application No. 13/489,321, filed June 5, 2012 [E-109-2007/1- US-04]; 6. US Application No. 14/263,703, filed April 28, 2014 [E-109-2007/ 1-US-011] The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be worldwide and the field of use may be limited to in vitro diagnostics of prion- associated diseases requiring FDA premarket approval, or the equivalent thereof outside of the United States, and USDA licensed veterinary diagnostics, or the equivalents thereof outside of the United States.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0422, which expires on August 31, 2015. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Cape Krusenstern National Monument Subsistence Resource Commission (SRC), Kobuk Valley National Park SRC, and Wrangell-St. Elias National Park SRC; Meeting
As required by the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16), the National Park Service (NPS) is hereby giving notice that the Cape Krusenstern National Monument Subsistence Resource Commission (SRC), Kobuk Valley National Park SRC, and Wrangell-St. Elias National Park SRC will hold meetings to develop and continue work on NPS subsistence program recommendations, and other related regulatory proposals and resource management issues. The NPS SRC program is authorized under Section 808 of the Alaska National Interest Lands Conservation Act (16 U.S.C. 3118), Title VIII.
Agency Information Collection Activities: Filing Instructions for V Nonimmigrant Status Applicants, Supplement A to Form I-539; Extension, Without Change, of a Currently Approved Collection
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 13, 2014, at 79 FR 47471, allowing for a 60-day public comment period. USCIS did not receive any comment in connection with the 60-day notice.
Agency Information Collection Activities: OMB-25, Special Immigrant Visas for Fourth Preference Employment-Based Broadcasters; Extension, Without Change, of a Currently Approved Collection
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 not receive any comment in connection with the 60-day notice.
Agency Information Collection Activities: Secondary Inspections Tool, Form M-1061; Extension, Without Change, of a Currently Approved Collection
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 4, 2014, at 79 FR 52739, allowing for a 60-day public comment period. USCIS did not receive any comment in connection with the 60-day notice.
Advisory Committee on Commercial Remote Sensing Meeting
The Advisory Committee on Commercial Remote Sensing (ACCRES) will meet December 5, 2014.
Privacy Act Regulations; Exemption for the Insider Threat Program
The Department of the Interior is issuing a final rule to amend its regulations to exempt certain records in the Insider Threat Program from one or more provisions of the Privacy Act because of criminal, civil, and administrative law enforcement requirements.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel KATHLEEN; Invitation for Public Comments
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel WINKAPEW; Invitation for Public Comments
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel CATCH AND RELIEF; Invitation for Public Comments
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
39th Meeting: RTCA Special Committee 206, Aeronautical Information and Meteorological Data Link Services
The FAA is issuing this notice to advise the public of the thirty-ninth meeting of the RTCA Special Committee 206, Aeronautical Information and Meteorological Data Link Services.
Proposed Establishment of Class E Airspace; Spokane, WA
This action proposes to establish Class E airspace at Spokane, WA, to facilitate vectoring of Instrument Flight Rules (IFR) aircraft under control of Seattle Air Route Traffic Control Center (ARTCC). The FAA is proposing this action to enhance the safety and management of IFR operations within the National Airspace System (NAS).
Agency Information Collection Activities: Proposed Collection; Comment Request
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the Federal Register under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: 10 CFR Part 31, General Domestic Licenses for Byproduct Material. 2. Current OMB approval number: 3150-0016. 3. How often the collection is required: Reports are submitted as events occur. General license registration requests may be submitted at any time. Changes to the information on the registration may be submitted as they occur. 4. Who is required or asked to report: Persons receiving, possessing, using, or transferring devices containing byproduct material. 5. The number of annual respondents: 10,929 (971 NRC respondents, 9,958 Agreement State respondents). 6. The number of hours needed annually to complete the requirement or request: 36,186 hours (4,843 hours for NRC licensees + 31,343 hours for Agreement State licensees). 7. Abstract: Part 31 of Title 10 of the Code of Federal Regulations (10 CFR), establishes general licenses for the possession and use of byproduct material in certain devices. General licensees are required to keep testing records and submit event reports identified in Part 31, which assist the NRC in determining with reasonable assurance that devices are operated safely and without radiological hazard to users or the public. Submit, by January 20, 2015, comments that address the following questions: 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? 2. Is the burden estimate accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology? The public may examine and have copied for a fee publicly-available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. The OMB clearance requests are available at the NRC's Web site: https://www.nrc.gov/public-involve/ doc-comment/omb/. The document will be available on the NRC's home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2014-0247. You may submit your comments by any of the following methods: Electronic comments go to https:// www.regulations.gov and search for Docket No. NRC-2014-0247. Mail comments to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Questions about the information collection requirements may be directed to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone at 301-415-6258, or by email to INFOCOLLECTS.Resource@NRC.GOV.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.