April 4, 2016 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 186
National Organic Standards Board (NOSB): Notice of Intent To Renew Charter and Call for Nominations
The National Organic Standards Board (NOSB) was established to assist in the development of standards for substances to be used in organic production and to advise the Secretary on the implementation of the Organic Foods Production Act of 1990 (OFPA). Through this Notice, USDA is announcing the following: its intent to renew the Charter of the NOSB, which expires on May 8, 2016; its call for nominations to fill five (5) upcoming vacancies for appointments in 2017, and its call for nominations for a pool of candidates to fill future unexpected vacancies in any of the position categories should that occur.
Culturally Significant Objects Imported for Exhibition Determinations: “Court and Cosmos: The Great Age of the Seljuqs” Exhibition
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257-1 of December 11, 2015), I hereby determine that the objects to be included in the exhibition ``Court and Cosmos: The Great Age of the Seljuqs,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Metropolitan Museum of Art, New York, New York, from on or about April 27, 2016, until on or about July 24, 2016, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Fisheries of the Exclusive Economic Zone Off Alaska; Northern Rockfish in the Bering Sea and Aleutian Islands Management Area.
NMFS is opening directed fishing for northern rockfish in the Bering Sea and Aleutian Islands Management Area (BSAI). This action is necessary to fully use the 2016 total allowable catch (TAC) of northern rockfish in the BSAI.
Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
The Food and Drug Administration (FDA or Agency) is proposing to amend its nonprescription (over-the-counter or OTC) drug regulations. The proposed rule, if finalized as proposed, would supplement the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). We are also proposing other changes to make the TEA process more efficient.
Labeling for Biosimilar Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Labeling for Biosimilar Products.'' This draft guidance is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products. The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert). This draft guidance provides an overview of FDA's recommendations for labeling for biosimilar products licensed under the Public Health Service Act (PHS Act).
Determination That PRONESTYL (Procainamide Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Proposed eCollection eComments Requested; National Institute of Justice Compliance Testing Program
The Department of Justice (DOJ), Office of Justice Programs (OJP), National Institute of Justice (NIJ) 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. This proposed information collection was previously published in the Federal Register at 81 FR 2911, on January 19, 2016, allowing for a 60 day comment period.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Report of Public Safety Officers Permanent and Total Disability
The Department of Justice (DOJ), Office of Justice Programs (OJP), Bureau of Justice Assistance, 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. This proposed information collection was previously published in the Federal Register at 81 FR 1212 on January 11, 2016 allowing for a 60 day comment period.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Report of Public Safety Officers Death Benefits
The Department of Justice (DOJ), Office of Justice Programs (OJP), Bureau of Justice Assistance, 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. This proposed information collection was previously published in the Federal Register at 81 FR 1223 on January 11, 2016 allowing for a 60 day comment period.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Claim for Death Benefits
The Department of Justice (DOJ), Office of Justice Programs (OJP), Bureau of Justice Assistance, 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. This proposed information collection was previously published in the Federal Register at 81 FR 1224, on January 11, 2016 allowing for a 60 day comment period.
Texas Disaster Number TX-00465
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4266-DR), dated 03/19/ 2016. Incident: Severe storms, tornadoes, and flooding. Incident Period: 03/07/2016 and continuing. Effective Date: 03/25/2016. Physical Loan Application Deadline Date: 05/18/2016. EIDL Loan Application Deadline Date: 12/19/2016.
Mississippi Disaster #MS-00084
This is a Notice of the Presidential declaration of a major disaster for the State of Mississippi (FEMA-4268-DR), dated 03/25/2016. Incident: Severe Storms and Flooding. Incident Period: 03/09/2016 and continuing. Effective Date: 03/25/2016. Physical Loan Application Deadline Date: 05/24/2016. Economic Injury (EIDL) Loan Application Deadline Date: 12/27/2016.
Pennsylvania Disaster #PA-00069
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Pennsylvania (FEMA-4267-DR), dated 03/23/2016. Incident: Severe Winter Storm and Snowstorm. Incident Period: 01/22/2016 through 01/23/2016. Effective Date: 03/23/2016. Physical Loan Application Deadline Date: 05/23/2016. Economic Injury (EIDL) Loan Application Deadline Date: 12/23/2016.
Extension of the Workers' Compensation Offset From Age 65 to Full Retirement Age-Achieving a Better Life Experience (ABLE) Act
This final rule adopts, with one additional change, the notice of proposed rulemaking (NPRM) that we published in the Federal Register on January 4, 2016. This final rule revises our rules by incorporating changes made by the ABLE Act to section 224(a) of the Social Security Act (Act). Under this final rule, the age at which disability insurance benefits (DIB) are no longer subject to reduction (offset) based on receipt of workers' compensation or public disability benefits (WC/PDB) changes from age 65 to the day the individual attains full retirement age.
Revisions to the Export Administration Regulations Based on the 2015 Missile Technology Control Regime Plenary Agreements
The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to reflect changes to the Missile Technology Control Regime (MTCR) Annex that were agreed to by MTCR member countries at the October 2015 Plenary in Rotterdam, Netherlands, and the April 2015 Technical Experts Meeting (TEM) in Bern, Switzerland. This final rule makes conforming changes to correlate the Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR) and other EAR provisions with the current MTCR Annex. This final rule revises six Export Control Classification Numbers (ECCNs) to implement the changes that were agreed to at the meetings and to better align the MT controls on the CCL with the MTCR Annex. In addition, this final rule makes a change to MT licensing policy to be consistent with the MTCR Annex General Minimum Software Note and the MTCR Annex General Technology Note that specify that a license for MT controlled items should also authorize certain minimum ``software'' and ``technology.'' This final rule also adds a new paragraph to the section of the EAR that specifies which changes to a license are considered ``non- material.'' This amendment will facilitate this rule's revised MT licensing policy, which will apply to all licenses for MT controlled items, except when excluded by a license condition.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of Alaska
NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2016 Pacific cod total allowable catch apportioned to vessels using pot gear in the Central Regulatory Area of the GOA.
Michigan; Amendment No. 1 to Notice of an Emergency Declaration
This notice amends the notice of an emergency for the State of Michigan (FEMA-3375-EM), dated January 16, 2016, and related determinations.
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Lending Limits
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 the renewal of an information collection, as required by the Paperwork Reduction Act of 1995 (PRA). 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 concerning renewal of its information collection titled, ``Lending Limits.''
Proposed Flood Hazard Determinations for Coconino County, Arizona and Incorporated Areas
The Federal Emergency Management Agency (FEMA) is withdrawing its proposed notice concerning proposed flood hazard determinations, which may include the addition or modification of any Base Flood Elevation, base flood depth, Special Flood Hazard Area boundary or zone designation, or regulatory floodway (herein after referred to as proposed flood hazard determinations) on the Flood Insurance Rate Maps and, where applicable, in the supporting Flood Insurance Study reports for Coconino County, Arizona, and Incorporated Areas.
Final Flood Hazard Determinations
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
Changes in Flood Hazard Determinations
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.
Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee
The Office of the Assistant Secretary for Health (OASH), within the Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The appointments of several Committee members are scheduled to end during the 2016 calendar year. Nominations of qualified candidates are being sought to fill the positions that are scheduled to be vacated.
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Examination Questionnaire
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 the renewal of an information collection, as required by the Paperwork Reduction Act of 1995 (PRA). 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 concerning renewal of its information collection titled, ``Examination Questionnaire.''
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Community and Economic Development Entities, Community Development Projects, and Other Public Welfare Investments
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). 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 concerning its information collection titled, ``Community and Economic Development Entities, Community Development Projects, and Other Public Welfare Investments,'' under 12 CFR 24 (``Part 24'').
Agency Information Collection Activities: Administrative Rulings
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security 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: Administrative Rulings. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with a change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Special Local Regulation; Charleston Race Week, Charleston Harbor, Charleston, SC
The Coast Guard is establishing a special local regulation on the waters of Charleston Harbor in Charleston, SC during the Charleston Race Week from April 15, 2016 through April 17, 2016. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. This regulation prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.
Special Local Regulation; Bucksport/Lake Murray Drag Boat Spring Nationals, Atlantic Intracoastal Waterway; Bucksport, SC
The Coast Guard is establishing a special local regulation on the Atlantic Intracoastal Waterway in Bucksport, South Carolina during the Bucksport/Lake Murray Drag Boat Spring Nationals, on June 4 and June 5, 2016. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. This regulation prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.
Challenges and Opportunities for Pumped Storage Hydropower
The Wind and Water Power Technologies Office within the U.S. Department of Energy (DOE) recently released a Request for Information to identify the challenges and opportunities faced by the pumped storage hydropower industry. DOE is now announcing two additional opportunities to obtain individual stakeholder insight into the technical and market challenges and potential pathways to facilitate the development of pumped storage in the U.S.: A public workshop and a subsequent webinar entitled, ``Challenges and Opportunities for Pumped Storage Hydropower.''
Fisheries of the Northeastern United States; Atlantic Herring Fishery; Framework Adjustment 4
NMFS implements approved measures in Framework 4 to the Atlantic Herring Fishery Management Plan. The New England Fishery Management Council developed Framework 4 to further enhance catch monitoring and address discarding in the herring fishery. The approved measures include: A requirement that vessels report slippage (i.e., catch discarded prior to sampling by an observer) via the vessel monitoring system; slippage consequences measures (i.e., requirement to move 15 nautical miles (27.78 km) or return to port following a slippage event); and clarifications to existing slippage measures and definitions. NMFS disapproved two measures in Framework 4. These measures would have required: Fish holds to be certified and observers to collect volumetric catch estimates of total catch; and fish holds to be empty of fish before leaving port, unless a waiver is issued by an authorized law enforcement officer. NMFS disapproved these measures because it determined that they are inconsistent with the Magnuson- Stevens Fishery Conservation and Management Act, the Administrative Procedure Act, and the Paperwork Reduction Act. Therefore, those two measures are not implemented in this action. Lastly, NMFS implements minor corrections to regulations to clarify their intent and ensure they are consistent with the Atlantic Herring Fishery Management Plan.
Comparability Protocols-Chemistry, Manufacturing, and Controls Information for New Animal Drugs; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (#156) entitled ``Comparability ProtocolsChemistry, Manufacturing, and Controls Information for New Animal Drugs.'' This document provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC) information. It is intended to provide recommendations to industry regarding comparability protocols that would be submitted in new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), or supplements to these applications. This guidance also applies to comparability protocols submitted in investigational new animal drug (INAD), generic investigational new animal drug (JINAD), and veterinary master file (VMF) submissions that are referenced in applications. FDA is providing this guidance in response to requests from those interested in using comparability protocols.
Ashley Resource Advisory Committee
The Ashley Resource Advisory Committee (RAC) will meet in Vernal, Utah. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: https://cloudapps-usda-gov.force.com/ FSSRS/RAC_Page?id=001t0000002JcvKAAS.
World Trade Center Health Program; Petition 010-Peripheral Neuropathy; Finding of Insufficient Evidence
On January 5, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 010) to add peripheral neuropathy to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add peripheral neuropathy to the List. The Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/ Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
New England Fishery Management Council; Public Meeting
The New England Fishery Management Council (Council, NEFMC) will hold a three-day meeting to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).
Prospective Grant of Exclusive License: Development of 5T4 Antibodies in Human Cancer Therapeutics and Diagnostics
This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Ovensa, Inc. (``Ovensa'') located in Ontario, Canada.
New Postal Product
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 203 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Section 512 Study: Extension of Time To Submit Requests To Participate in Roundtable
The United States Copyright Office is extending the deadline for the submission of requests to participate in the section 512 roundtables in New York and California, which were announced in its March 18, 2016 Notice of Inquiry. See 81 FR 14896.
Proposed Agency Information Collection Activities; Comment Request
The Board of Governors of the Federal Reserve System (Board or Federal Reserve) invites comment on a proposal to revise the FR Y-7Q by collecting fourteen new data items to monitor compliance with enhanced prudential standards for foreign banking organizations (FBOs) adopted pursuant to Subparts N and O of Regulation YY (12 CFR part 252). The proposal would require an FBO with total consolidated assets of $50 billion or more to report the new data items in order to determine whether the FBO meets capital adequacy standards at the consolidated level that are consistent with the Basel capital framework. On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.
Proposed Agency Information Collection Activities; Comment Request
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), to approve of and assign OMB numbers to collection of information requests and requirements conducted or sponsored by the Board. Board- approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number.
Proposed Agency Information Collection Activities; Comment Request
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), to approve of and assign OMB numbers to collection of information requests and requirements conducted or sponsored by the Board. Board- approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number.
Commission Information Collection Activities (FERC Form 6-Q); Comment Request; Extension
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC Form 6-Q (Quarterly Financial Report of Oil Pipeline Companies).
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