April 12, 2016 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 121
Notice of Termination; 10169 St. Stephen State Bank, St. Stephen, Minnesota
Document Number: 2016-08342
Type: Notice
Date: 2016-04-12
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2016-08341
Type: Notice
Date: 2016-04-12
Agency: Federal Reserve System, Agencies and Commissions
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2016-08340
Type: Notice
Date: 2016-04-12
Agency: Federal Reserve System, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2016-08339
Type: Notice
Date: 2016-04-12
Agency: Department of Agriculture, Rural Utility Service
Determination of Regulatory Review Period for Purposes of Patent Extension; GAZYVA
Document Number: 2016-08338
Type: Notice
Date: 2016-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for GAZYVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ADEMPAS
Document Number: 2016-08337
Type: Notice
Date: 2016-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ADEMPAS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS
Document Number: 2016-08336
Type: Notice
Date: 2016-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of a new drug application (NDA) for LUVERIS (lutropin alpha for injection) held by EMD Serono, One Technology Place, Rockland, MA 02370. EMD Serono has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Safety Considerations for Product Design To Minimize Medication Errors; Guidance for Industry; Availability
Document Number: 2016-08335
Type: Notice
Date: 2016-04-12
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 guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors.'' The guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), and abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs. This guidance provides sponsors, applicants, and manufacturers with a set of principles to consider while developing drug products using a systems approach to minimize medication errors relating to product design and container closure design. The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drug products. This guidance also provides examples of product designs that resulted in postmarketing error.
Determination of Regulatory Review Period for Purposes of Patent Extension; APTIOM
Document Number: 2016-08334
Type: Notice
Date: 2016-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for APTIOM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; APOQUEL
Document Number: 2016-08333
Type: Notice
Date: 2016-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for APOQUEL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparing Food Safety Knowledge, Attitude and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers
Document Number: 2016-08332
Type: Notice
Date: 2016-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Feed Regulatory Program Standards
Document Number: 2016-08331
Type: Notice
Date: 2016-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's Animal Feed Regulatory Program Standards (AFRPS).
Donor Screening Recommendations To Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability; Correction
Document Number: 2016-08330
Type: Notice
Date: 2016-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Monday, March 7, 2016 (81 FR 11808). The document announced a guidance for industry entitled ``Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products.'' The document was published with an incorrect docket number in the ADDRESSES section. This document corrects that error.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens
Document Number: 2016-08329
Type: Notice
Date: 2016-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing
Document Number: 2016-08327
Type: Notice
Date: 2016-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is proposing to withdraw approval of all new animal drug applications (NADAs) providing for use of carbadox in medicated swine feed. This action is based on CVM's determination that the use of carbadox under the approved conditions of use results in residues of carcinogenic concern in the edible tissues of the treated swine.
Migratory Bird Hunting; Final Frameworks for Migratory Bird Hunting Regulations
Document Number: 2016-08326
Type: Rule
Date: 2016-04-12
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, published a final rule in the Federal Register on March 28, 2016, that prescribes final frameworks from which States may select season dates, limits, and other options for the 2016-17 migratory bird hunting seasons. In that rule, we made an error in the daily bag limit for canvasbacks in Alaska. We intended to increase the daily bag limit for canvasbacks in Alaska, as we did for the rest of the United States, to 2 birds. We also included an incorrect description for the Special Early Canada Goose Unit in South Dakota. With this document, we correct our errors.
Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest
Document Number: 2016-08325
Type: Notice
Date: 2016-04-12
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Portable Electronic Devices and Components Thereof, DN 3130; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing under section 210.8(b) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(b)).
Cyber Security at Fuel Cycle Facilities
Document Number: 2016-08324
Type: Rule
Date: 2016-04-12
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is making available a final regulatory basis document to support a rulemaking that would amend its regulations by adopting new cyber security requirements for certain nuclear fuel cycle facility (FCF) licensees in order to address safety, security, and safeguards consequences of concern. The NRC is not seeking public comments on this document. There will be an opportunity for formal public comment on the proposed rule when it is published in the Federal Register.
Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations
Document Number: 2016-08323
Type: Notice
Date: 2016-04-12
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued, from March 15, 2016, to March 28, 2016. The last biweekly notice was published on March 29, 2016.
Mail Classification Schedule
Document Number: 2016-08322
Type: Proposed Rule
Date: 2016-04-12
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is proposing rules which amend existing rules related to the Mail Classification Schedule and its associated product lists. The proposed rules revise some existing rules in order to better conform with current Commission practices related to the Mail Classification Schedule. The Commission invites public comment on the proposed rules.
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Notice Regarding Unauthorized Access to Customer Information
Document Number: 2016-08321
Type: Notice
Date: 2016-04-12
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 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 its information collection titled, ``Notice Regarding Unauthorized Access to Customer Information.''
Petition for Exemption; Summary of Petition Received; Invictus Technical Solutions LLC
Document Number: 2016-08320
Type: Notice
Date: 2016-04-12
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
RESTORE Act Spill Impact Component Allocation
Document Number: 2016-08319
Type: Rule
Date: 2016-04-12
This document confirms that on April 4, 2016, the United States District Court for the Eastern District of Louisiana entered a consent decree (Consent Decree) among the United States; the states of Alabama, Florida, Louisiana, Mississippi and Texas; and BP Exploration and Production Inc. with respect to the civil penalty and natural resource damages in case number MDL No. 2179. The Gulf Coast Ecosystem Restoration Council (Council) regulation (Spill Impact Regulation) that implements the Spill Impact Component Allocation of the Resources and Ecosystems Sustainability, Tourist Opportunities, and Revived Economies of the Gulf Coast States Act of 2012 (RESTORE Act) is effective as of the date of publication of this document.
Emergency Funding for Puerto Rico Department of Health, Zika Virus Outbreak
Document Number: 2016-08318
Type: Notice
Date: 2016-04-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The U.S. Centers for Disease Control and Prevention (CDC) is providing $3,700,000 in urgent funding through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement to the Puerto Rico Department of Health (PRDOH) to combat the current outbreak of Zika virus.
Petition for Exemption; Summary of Petition Received; Cirrus Design Corporation
Document Number: 2016-08316
Type: Notice
Date: 2016-04-12
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Reporting and Recordkeeping Requirements Under OMB Review
Document Number: 2016-08315
Type: Notice
Date: 2016-04-12
Agency: Small Business Administration, Agencies and Commissions
The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA) (44 U.S.C. Chapter 35), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the Federal Register notifying the public that the agency has made such a submission. This notice also allows an additional 30 days for public comments.
Petition for Exemption; Summary of Petition Received; Martin UAV
Document Number: 2016-08314
Type: Notice
Date: 2016-04-12
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Petition for Exemption; Summary of Petition Received; The Dobbins Company
Document Number: 2016-08313
Type: Notice
Date: 2016-04-12
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Petition for Exemption; Summary of Petition Received; AeroLogix Consulting Inc.
Document Number: 2016-08312
Type: Notice
Date: 2016-04-12
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Petition for Exemption; Summary of Petition Received; Walt Disney Parks and Resorts U.S., Inc.
Document Number: 2016-08311
Type: Notice
Date: 2016-04-12
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
District of Columbia Disaster #DC-00007
Document Number: 2016-08310
Type: Notice
Date: 2016-04-12
Agency: Small Business Administration, Agencies and Commissions
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the District of Columbia (FEMA- 4260-DR), dated 04/01/2016. Incident: Snowstorm. Incident Period: 01/22/2016 through 01/23/2016. Effective date: 04/01/2016. Physical Loan Application Deadline Date: 05/31/2016. Economic Injury (EIDL) Loan Application Deadline Date: 01/03/2017.
Mississippi Disaster Number MS-00084
Document Number: 2016-08309
Type: Notice
Date: 2016-04-12
Agency: Small Business Administration, Agencies and Commissions
This is an amendment 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: 03/31/2016. Physical Loan Application Deadline Date: 05/24/2016. EIDL Loan Application Deadline Date: 12/27/2016.
Texas Disaster Number TX-00465
Document Number: 2016-08308
Type: Notice
Date: 2016-04-12
Agency: Small Business Administration, Agencies and Commissions
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 through 03/29/2016. Effective Date: 03/29/2016. Physical Loan Application Deadline Date: 05/18/2016. Eidl Loan Application Deadline Date: 12/19/2016.
Türkiye Sinai Kalkinma Bankasi A.Ş.; Notice of Application
Document Number: 2016-08298
Type: Notice
Date: 2016-04-12
Agency: Securities and Exchange Commission, Agencies and Commissions
Applicant: T[uuml]rkiye Sinai Kalkinma Bankasi A.[Scedil]. (``Applicant''). Summary of Application: Applicant, a banking institution organized as a public joint stock company of unlimited duration under the laws of the Republic of Turkey (``Turkey'') requests an order exempting it from all provisions of the Act in connection with the offer and sale of its debt securities in the United States. Filing Dates: The application was filed on July 14, 2015, and amended on November 25, 2015 and March 14, 2016. Hearing or Notification of Hearing: An order granting the application will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicant with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on May 2, 2016, and should be accompanied by proof of service on applicant, in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state the nature of the writer's interest, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-08297
Type: Notice
Date: 2016-04-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Drawbridge Operation Regulation; Connecticut River, East Haddam, CT
Document Number: 2016-08296
Type: Rule
Date: 2016-04-12
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Route 82 Bridge across the Connecticut River, mile 16.8, at East Haddam, Connecticut. This deviation is necessary to allow the bridge owner to perform emergency repairs at the bridge.
FY16 Competitive Funding Opportunity: Grants for Buses and Bus Facilities and Low or No Emission Grant Programs; 5339(b) Grants for Buses and Bus Facilities Program and 5339(c) Low or No Emission Program-Correction
Document Number: 2016-08295
Type: Notice
Date: 2016-04-12
Agency: Federal Transit Administration, Department of Transportation
On March 29, 2016, the Federal Transit Administration (FTA) published a Notice of Funding Opportunity (NOFO) in the Federal Register announcing the availability of approximately $211 million for Grants for Buses and Bus Facilities and $55 million for Low or No Emission Grants. The notice provided incomplete information regarding FTA's Buy America and Disadvantage Business Enterprise (DBE) requirements. Additionally, the NOFO was missing information in one place about how to submit applications through www.grants.gov. This notice corrects the March 29 notice.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2016-08294
Type: Notice
Date: 2016-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-08293
Type: Notice
Date: 2016-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Fogarty International Center; Notice of Meeting
Document Number: 2016-08292
Type: Notice
Date: 2016-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-08291
Type: Notice
Date: 2016-04-12
Agency: Department of Health and Human Services, National Institutes of Health