September 2015 – Federal Register Recent Federal Regulation Documents

Results 301 - 350 of 2,488
Notice of Commission Staff Attendance
Document Number: 2015-24536
Type: Notice
Date: 2015-09-28
Agency: Department of Energy, Federal Energy Regulatory Commission
Northern Natural Gas Company; Notice of Application
Document Number: 2015-24533
Type: Notice
Date: 2015-09-28
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2015-24532
Type: Notice
Date: 2015-09-28
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #2
Document Number: 2015-24531
Type: Notice
Date: 2015-09-28
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2015-24530
Type: Notice
Date: 2015-09-28
Agency: Department of Energy, Federal Energy Regulatory Commission
Submission for OMB Review; Comment Request
Document Number: 2015-24526
Type: Notice
Date: 2015-09-28
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Biosimilar User Fee Act; Public Meeting
Document Number: 2015-24524
Type: Notice
Date: 2015-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect user fees for the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA begin the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment on the BsUFA performance goals as the Agency begins the process to reauthorize the program in FYs 2018-2022.
Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978
Document Number: 2015-24523
Type: Notice
Date: 2015-09-28
Agency: National Science Foundation, Agencies and Commissions
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 671 of the Code of Federal Regulations. This is the required notice of permit applications received.
Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978
Document Number: 2015-24522
Type: Notice
Date: 2015-09-28
Agency: National Science Foundation, Agencies and Commissions
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.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2015-24521
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2015-24520
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Application for Naturalization, Form N-400; Revision of a Currently Approved Collection
Document Number: 2015-24519
Type: Notice
Date: 2015-09-28
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 April 8, 2015, at 80 FR 18856, allowing for a 60-day public comment period. USCIS did receive 6 comments in connection with the 60-day notice.
Investor Advisory Committee Meeting
Document Number: 2015-24514
Type: Notice
Date: 2015-09-28
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, is providing notice that it will hold a public meeting. The public is invited to submit written statements to the Committee.
Actions Taken at September 10, 2015, Meeting
Document Number: 2015-24513
Type: Notice
Date: 2015-09-28
Agency: Susquehanna River Basin Commission, Agencies and Commissions
As part of its regular business meeting held on September 10, 2015, in Binghamton, New York, the Commission took the following actions: (1) Approved or tabled the applications of certain water resources projects; (2) approved a request from Panda Power Funds for transfer of ownership of Hummel Station LLC; (3) accepted a settlement in lieu of penalty from Downs Racing L.P.; and (4) took additional actions, as set forth in the SUPPLEMENTARY INFORMATION below.
Submission for OMB Review; comments request
Document Number: 2015-24512
Type: Notice
Date: 2015-09-28
Agency: Overseas Private Investment Corporation, Agencies and Commissions
Under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35), agencies are required to publish a Notice in the Federal Register notifying the public that the agency is submitting an existing collection in use without an OMB control number for OMB review and approval, and requests public review and comment on the submission. OPIC received no comments in response to the sixty (60) day notice. The purpose of this notice is to allow an additional thirty (30) days for public comments to be submitted. Comments are being solicited on the need for the information; the accuracy of OPIC's burden estimate; the quality, practical utility, and clarity of the information to be collected; and ways to minimize reporting the burden, including automated collected techniques and uses of other forms of technology.
Applications for New Awards; Low-Cost, Short-Duration Evaluation of Education Interventions and Low-Cost, Short-Duration Evaluation of Special Education Interventions
Document Number: 2015-24511
Type: Notice
Date: 2015-09-28
Agency: Department of Education
The Deputy Director for Policy and Research, delegated the duties of the Director, of the Institute of Education Sciences (Institute) announces the Institute's FY 2016 grant competition for Low-Cost, Short-Duration Evaluation of Education Interventions and Low- Cost, Short-Duration Evaluation of Special Education Interventions. The Deputy Director for Policy and Research takes this action under the Education Sciences Reform Act of 2002. The Institute's purpose in awarding these grants is to support rigorous evaluations of education interventions that State educational agencies (SEAs) or local educational agencies (LEAs) believe will produce meaningful improvements in student outcomes within a short period (for example, within a single semester or academic year), that can be conducted at low cost, and that will provide policymakers with valid and useful results more rapidly than is typically achieved in education research.
M7(R1) Addendum to ICH M7; International Conference on Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2015-24510
Type: Notice
Date: 2015-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound- Specific Acceptable Intakes.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance, an addendum to the ICH M7 guidance of May 28, 2015, provides guidance on acceptable intake limits derived for some chemicals that are considered to be mutagens and carcinogens, and that were selected because they are commonly used in pharmaceutical manufacturing or are useful in illustrating the principles for deriving compound-specific intakes as described in ICH M7. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.
Labeling Lower-Dose Estrogen-Alone Products for Symptoms of Vulvar and Vaginal Atrophy
Document Number: 2015-24509
Type: Notice
Date: 2015-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on the topic of the labeling for lower-dose estrogen products delivered vaginally, intended to treat moderate to severe symptoms of vulvar and vaginal atrophy (VVA) due to menopause. Lower-dose estrogen products means products that contain less than the 0.625 milligrams (mg) of conjugated estrogens used in the Women's Health Initiative Study, and estradiol products containing 0.0375 mg and below. Lower-dose estrogen products are now approved for the treatment of moderate to severe symptoms of VVA due to menopause, and some in the scientific/medical community have questioned whether the current ``Boxed Warnings'' section in the labeling is applicable in whole or in part to these lower-dose estrogen products. This meeting, a scientific workshop, will provide an opportunity for FDA to seek input from experts on the Boxed Warnings section, estrogen exposure data, and pharmacokinetic (PK)/ pharmacodynamic (PD) relationships relative to labeling lower-dose estrogen-alone products intended to treat moderate to severe symptoms of VVA due to menopause.
Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2016
Document Number: 2015-24508
Type: Notice
Date: 2015-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of certain rare pediatric disease product applications, submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2016 and outlines the payment procedures for such fees.
Digital Performance Right in Sound Recordings and Ephemeral Recordings
Document Number: 2015-24506
Type: Rule
Date: 2015-09-28
Agency: Copyright Royalty Board, Library of Congress, Library of Congress, Agencies and Commissions
The Copyright Royalty Judges publish final regulations that set the rates and terms for the digital performances of sound recordings by certain noncommercial educational webcasters and for the making of ephemeral recordings necessary to facilitate those transmissions for the period commencing January 1, 2016, and ending on December 31, 2020.
Notice of Surrender of License of Small Business Investment Company
Document Number: 2015-24503
Type: Notice
Date: 2015-09-28
Agency: Small Business Administration, Agencies and Commissions
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Radionuclides (Renewal)
Document Number: 2015-24500
Type: Notice
Date: 2015-09-28
Agency: Environmental Protection Agency
The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Radionuclides (Renewal)'' (EPA ICR No. 1100.15, OMB Control No. 2060-0249) 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. Public comments were previously requested via the Federal Register 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.
National Council on the Arts 186th Meeting
Document Number: 2015-24499
Type: Notice
Date: 2015-09-28
Agency: National Foundation on the Arts and the Humanities, Agencies and Commissions, National Endowment for the Arts
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, notice is hereby given that a meeting of the National Council on the Arts will be held at Constitution Center, 400 7th St. SW., Washington, DC 20506. Agenda times are approximate.
Proposed Flood Hazard Determinations
Document Number: 2015-24497
Type: Notice
Date: 2015-09-28
Agency: Federal Emergency Management Agency, Department of Homeland Security
On June 8, 2015, FEMA published in the Federal Register a proposed flood hazard determination notice that contained an erroneous table. This notice provides corrections to that table, to be used in lieu of the information published at 80 FR 32396. The table provided here represents the proposed flood hazard determinations and communities affected for Humboldt County, California, and Incorporated Areas.
Changes in Flood Hazard Determinations
Document Number: 2015-24496
Type: Notice
Date: 2015-09-28
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Title 44, Part 65 of the Code of Federal Regulations (44 CFR part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
Proposed Collection of Information: Report/Application for Relief on Account of Loss, Theft, or Destruction of U.S. Bearer Securities (Organizations)
Document Number: 2015-24495
Type: Notice
Date: 2015-09-28
Agency: 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 a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Report/Application for Relief on Account of Loss, Theft, or Destruction of U.S. Bearer Securities (Organizations).
Proposed Collection of Information: Report/Application for Relief on Account of Loss, Theft, or Destruction of U.S. Bearer Securities (Individuals)
Document Number: 2015-24494
Type: Notice
Date: 2015-09-28
Agency: 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 a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Report/Application for Relief on Account of Loss, Theft, or Destruction of U.S. Bearer Securities (Individuals).
Proposed Collection of Information: Certificate of Identity
Document Number: 2015-24493
Type: Notice
Date: 2015-09-28
Agency: 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 a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Certificate of Identity.
Proposed Collection of Information: Pools and Associations-Annual Letter
Document Number: 2015-24492
Type: Notice
Date: 2015-09-28
Agency: 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 a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning Pools and AssociationsAnnual Letter.
Report on the Criteria and Methodology for Determining the Eligibility of Candidate Countries for Millennium Challenge Account Assistance in Fiscal Year 2016
Document Number: 2015-24490
Type: Notice
Date: 2015-09-28
Agency: Millennium Challenge Corporation, Agencies and Commissions
This report to Congress is provided in accordance with Section 608(b) of the Millennium Challenge Act of 2003, as amended, 22 U.S.C. 7707(b) (the ``Act'').
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-24489
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-24488
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meetings
Document Number: 2015-24487
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-24486
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2015-24485
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Cancellation of Meeting
Document Number: 2015-24484
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-24483
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2015-24482
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2015-24481
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2015-24480
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2015-24479
Type: Notice
Date: 2015-09-28
Agency: Department of Health and Human Services, National Institutes of Health
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