August 18, 2015 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 115
Principal ETMF Trust, et al.; Notice of Application
Summary of Application: Applicants request an order (``Order'') that permits: (a) Actively managed series of certain open- end management investment companies to issue shares (``Shares'') redeemable in large aggregations only (``Creation Units''); (b) secondary market transactions in Shares to occur at the next-determined net asset value plus or minus a market-determined premium or discount that may vary during the trading day; (c) certain series to pay redemption proceeds, under certain circumstances, more than seven days from the tender of Shares for redemption; (d) certain affiliated persons of the series to deposit securities into, and receive securities from, the series in connection with the purchase and redemption of Creation Units; (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the series to acquire Shares; and (f) certain series to create and redeem Shares in kind in a master-feeder structure. The Order would incorporate by reference terms and conditions of a previous order granting the same relief sought by applicants, as that order may be amended from time to time (``Reference Order'').\1\
Groundfish Operational Assessment Public Meeting
NMFS and the Northeast Regional Stock Assessment Workshop (SAW) will convene a peer review of Operational Stock Assessments of twenty fish stocks. These stocks are managed by the New England Fishery Management Council and are included within the Northeast Multispecies Fishery Management Plan. This will be a formal, scientific peer review of operational assessments which incorporate recent data. Results of the review will be used as a basis for management decisions for fish stocks in U.S. waters of the northwest Atlantic. Assessments are prepared by stock assessment scientists primarily from the Northeast Fisheries Science Center and reviewed by a panel of stock assessment experts. The public is invited to attend the presentations and discussions by reviewers and scientists who have participated in the stock assessment process.
Ironing Tables From China; Scheduling of an Expedited Five-Year Review
The Commission hereby gives notice of the scheduling of an expedited review pursuant to the Tariff Act of 1930 (``the Act'') to determine whether revocation of the antidumping duty order on ironing tables from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device
The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the esophageal thermal regulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2
The Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) are announcing support for the 3.2 version (see section II. Exceptions) of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Implementation Guide (SDTM IG 3.2), an update to the FDA Data Standards Catalog (Catalog), and availability of validation rules for the 3.2 version. SDTM IG 3.2 has been available from CDISC since December 2013. FDA is encouraging sponsors and applicants to use SDTM IG 3.2 (see section II. Exceptions) in investigational study data provided in regulatory submissions to CBER and to CDER.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Cadmium in General Industry Standard
The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Cadmium in General Industry Standard,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. Public comments on the ICR are invited.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Authorization for Release of Medical Information for Black Lung Benefits
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, ``Authorization for Release of Medical Information for Black Lung Benefits,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). Public comments on the ICR are invited.
Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Providing Submissions in Electronic FormatPostmarketing Safety Reports for Vaccines; Guidance for Industry.'' The guidance document provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national vaccine safety surveillance program that is co-sponsored by the Centers for Disease Control and Prevention (CDC) and FDA. FDA published in the Federal Register a final rule requiring that certain postmarketing safety reports for human drug and biological products, including vaccines, be submitted to FDA in an electronic format that the Agency can process, review, and archive. The guidance is intended to help applicants required to submit postmarketing safety reports involving vaccine products to comply with the final rule. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2014, and supersedes the document entitled ``Guidance for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS-1)'' dated September 1998.
Gulf of Mexico Fishery Management Council; Public Meeting
The Gulf of Mexico Fishery Management Council will hold a two- day meeting of its Standing and Special Reef Fish Scientific and Statistical Committee (SSC).
Mack Trucks, Inc., Receipt of Petition for Decision of Inconsequential Noncompliance
Mack Trucks, Inc. (Mack), has determined that certain model year (MY) 2014-2016 Mack LEU model incomplete vehicles do not fully comply with paragraphs S5.3.3 and S5.3.4 of Federal Motor Vehicle Safety Standard (FMVSS) No. 121, Air Brake Systems. Mack has filed an appropriate report dated April 27, 2015, pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility and Reports.
Pilot Program for Medical Device Reporting on Malfunctions
The Food and Drug Administration (FDA) is soliciting nominations for participation in a pilot program for the submission of medical device reports for malfunctions of class I devices and certain class II devices in summary format on a quarterly basis. Under the Medical Device Reporting on Malfunctions pilot program, FDA intends to work with manufacturers to identify candidates for the pilot program and intends to continue to accept nominations until candidates for the pilot program have been selected.
Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.'' FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA's thinking regarding certain non-clinical testing for these devices. While FDA is considering more substantial updates to the ``Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems'' guidance (http:/ /www.fda.gov/medicaldevices/deviceregulationandguidance/ guidancedocuments/ucm071863.htm), we are issuing this update on select sections in order to notify the industry in a timely manner of our revised recommendations.
Uncomplicated Gonorrhea: Developing Drugs for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Uncomplicated Gonorrhea: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated gonorrhea. This guidance finalizes the draft guidance of the same name issued on June 19, 2014.
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.
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.
Revisions to Framework Adjustment 53 to the Northeast Multispecies Fishery Management Plan and Sector Annual Catch Entitlements; Updated Annual Catch Limits for Sectors and the Common Pool for Fishing Year 2015
Based on the final Northeast multispecies sector rosters submitted as of May 1, 2015, we are adjusting the fishing year 2015 specification of annual catch limits for commercial groundfish vessels, as well as sector annual catch entitlements and common pool allocations for groundfish stocks. This revision to fishing year 2015 catch levels is necessary to account for changes in the number of participants electing to fish in either sectors or the common pool fishery. This action details unused sector quotas that may be carried over from fishing year 2014 to fishing year 2015. This action also reduces the fishing year 2015 common pool allocation of Eastern Georges Bank cod and adjusts common pool incidental catch limits to account for a common pool fishing year 2014 overage.
Prestressed Concrete Steel Wire Strand From China; Scheduling of Expedited Five-Year Reviews
The Commission hereby gives notice of the scheduling of expedited reviews pursuant to the Tariff Act of 1930 (``the Act'') to determine whether revocation of the antidumping duty and countervailing duty orders on prestressed concrete steel wire strand from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
Special Conditions: Cessna Airplane Company Model 680A Airplane, Side-Facing Seats Equipped With Airbag Systems
This action proposes special conditions for the Cessna Model 680A airplane. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. This design features side-facing seats equipped with airbag systems. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 Airplanes; Flight Envelope Protection, High-Speed Limiting
These special conditions are issued for the Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 airplanes. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Gulfstream Model GVII-G500 Airplanes, Side-Stick Controllers; Controllability and Maneuverability
This action proposes special conditions for Gulfstream Model GVII-G500 airplanes. These airplanes will have a novel or unusual design feature associated with side-stick controllers, instead of conventional-control wheel-and-column design, for pitch and roll control. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Gulfstream Model GVII-G500 Airplanes, Automatic Speed Protection for Design Dive Speed
This action proposes special conditions for the Gulfstream Model GVII-G500 airplanes. These airplanes will have a novel or unusual design feature associated with a reduced margin between design cruising speed, VC/MC, and design diving speed, VD/MD, based on the incorporation of a high-speed protection system that limits nose-down pilot authority at speeds above VC/MC. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplanes; Electronic Flight Control System: Control Surface Position Awareness
These special conditions are issued for Gulfstream Model GVII- G500 airplanes. These airplanes have a novel or unusual design feature associated with control-surface awareness provided by the electronic flight-control system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Renewal of Department of Defense Federal Advisory Committees
The Department of Defense (DoD) is publishing this notice to announce that it is renewing the charter for the Defense Policy Board (``the Board'').
Reporting and Recordkeeping Requirements Under OMB Review
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.
South Dakota Disaster #SD-00067
This is a Notice of the Presidential declaration of a major disaster for the State of South Dakota (FEMA-4237-DR), dated 08/07/ 2015. Incident: Severe Storms, Straight-line Winds, and Flooding. Incident Period: 05/08/2015 through 05/29/2015. Effective Date: 08/07/2015. Physical Loan Application Deadline Date: 10/06/2015. Economic Injury (EIDL) Loan Application Deadline Date: 05/07/2016.
West Virginia Disaster #WV-00041
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of West Virginia (FEMA-4236-DR), dated 08/07/2015. Incident: Severe Storms, Straight-line Winds, Flooding, Landslides, and Mudslides. Incident Period: 07/10/2015 through 07/14/2015. Effective Date: 08/07/2015. Physical Loan Application Deadline Date: 10/06/2015. ECONOMIC INJURY (EIDL) LOAN APPLICATION DEADLINE DATE: 05/07/2016.
Missouri Disaster #MO-00076
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of MISSOURI (FEMA- 4238-DR), dated 08/07/2015. Incident: Severe Storms, Tornadoes, Straight-line Winds, and Flooding. Incident Period: 05/15/2015 through 07/27/2015. Effective Date: 08/07/2015. Physical Loan Application Deadline Date: 10/06/2015. Economic Injury (EIDL) Loan Application Deadline Date: 05/07/2016.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
In accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Board, the Federal Deposit Insurance Corporation (FDIC), and the Office of the Comptroller of the Currency (OCC) (collectively, the agencies) 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. On May 6, 2015, the Board, under the auspices of the Federal Financial Institutions Examination Council (FFIEC) and on behalf of the agencies, published a notice in the Federal Register (80 FR 26050) requesting public comment on the extension, without revision, of the Report of Assets and Liabilities of U.S. Branches and Agencies of Foreign Banks (FFIEC 002), the Report of Assets and Liabilities of a Non-U.S. Branch that is Managed or Controlled by a U.S. Branch or Agency of a Foreign (Non-U.S.) Bank (FFIEC 002S), and the Country Exposure Report for U.S. Branches and Agencies of Foreign Banks (FFIEC 019), which are currently approved information collections. The comment period for this notice expired on July 6, 2015. The agencies received one comment expressing support for the renewal of the FFIEC 002 and FFIEC 002S. The Board hereby gives notice that it plans to submit to OMB on behalf of the agencies a request for approval of the extension, without revision, of the FFIEC 002, FFIEC 002S, and FFIEC 019.
Hazardous Materials: Information Collection Activities
In accordance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Requests (ICRs) discussed below will be forwarded to the Office of Management and Budget (OMB) for renewal and extension. These ICRs describe the nature of the information collections and their expected burdens. A Federal Register notice with a 60-day comment period soliciting comments on these ICRs was published in the Federal Register on April 29, 2015 [80 FR 23582] under Docket No. PHMSA-2015-0098 (Notice No. 15-8). PHMSA did not receive any comments in response to the April 29, 2015 notice.
Certain Hot-Rolled Steel Flat Products from Australia, Brazil, Japan, Korea, the Netherlands, Turkey, and the United Kingdom; Institution of Antidumping and Countervailing Duty Investigations and Scheduling of Preliminary Phase Investigations
The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-545-547 and 731-TA-1291- 1297 (Preliminary) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of certain hot-rolled steel flat products (``hot-rolled steel'') from Australia, Brazil, Japan, Korea, the Netherlands, Turkey, and the United Kingdom, provided for in subheadings 7208.10.15, 7208.10.30, 7208.10.60, 7208.25.30, 7208.25.60, 7208.26.00, 7208.27.00, 7208.36.00, 7208.37.00, 7208.38.00, 7208.39.00, 7208.40.60, 7208.53.00, 7208.54.00, 7208.90.00, 7210.70.30, 7210.90.90, 7211.14.00, 7211.19.15, 7211.19.20, 7211.19.30, 7211.19.45, 7211.19.60, 7211.19.75, 7211.90.00, 7212.40.10, 7212.40.50, 7212.50.00, 7225.11.00, 7225.19.00, 7225.30.30, 7225.30.70, 7225.40.70, 7225.99.00, 7226.11.10, 7226.11.90, 7226.19.10, 7226.19.90, 7226.91.50, 7226.91.70, 7226.91.80, and 7226.99.01 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less-than-fair- value and alleged to be subsidized by the governments of Brazil, Korea, and the United Kingdom. Unless the Department of Commerce extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by September 25, 2015. The Commission's views must be transmitted to Commerce within five business days thereafter, or by October 2, 2015.
60-Day Notice of Proposed Information Collection: Electronic Application for Immigration Visa and Alien Registration.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
Petition for Exemption; Summary of Petition Received; Ameriflight
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.
Safety Zones; Eighth Coast Guard District Annual and Recurring Safety Zones Update
The Coast Guard is amending and updating its current list of recurring safety zone regulations that take place in the Eighth Coast Guard District area of responsibility (AOR). This final rule informs the public of regularly scheduled events that require additional safety measures through establishing a safety zone. Through this final rule, the list of recurring safety zones is updated with revisions, additional events, and removal of events that no longer take place in the Eighth Coast Guard District AOR. When these safety zones are enforced, vessel traffic is restricted from specified areas. Additionally, this one rulemaking project reduces administrative costs involved in producing a separate rule for each individual recurring safety zone and serves to provide notice of the known recurring safety zones throughout the year.
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