2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of August 14, 2017. In the notice, FDA requested comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.'' The purpose of this document is to outline FDA's recommendations and expectations for the evaluation and reporting of age, race, and ethnicity data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, race, and ethnic groups.

Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Mark Tobey: Threading Light,'' 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 Addison Gallery of American Art at Phillips Academy, Andover, Massachusetts, from on or about November 4, 2017, until on or about March 11, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Union Pacific Railroad Drawbridge across the Carquinez Strait, mile 7.0, at Martinez, CA. The deviation is necessary to allow advance notification for openings due to mechanical issues at the bridge and to conduct repairs to resolve said issues. This deviation requires the bridge to open on signal if at least 30 minutes notice is given to the bridge operator from approaching vessels and allows the bridge to remain in the closed-to- navigation during operating equipment replacement.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

We propose to adopt a new airworthiness directive (AD) for all General Electric Company (GE) CF6-80A, -80A1, -80A2, and -80A3 turbofan engines. This proposed AD was prompted by high cycle fatigue (HCF) cracking of the low-pressure turbine (LPT) stage 3 nozzles. This proposed AD would require replacement of the LPT stage 3 nozzles. We are proposing this AD to address the unsafe condition on these products.

NMFS announces a meeting of the Permanent Advisory Committee (PAC) to advise the U.S. Commissioners to the Western and Central Pacific Fisheries Commission (WCPFC) on October 24-October 25, 2017. Meeting topics are provided under the SUPPLEMENTARY INFORMATION section of this notice.

The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, ``Hoist Operators' Physical Fitness'' 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). Public comments on the ICR are invited.

The Secretary of Homeland Security has determined, pursuant to law, that it is necessary to waive certain laws, regulations and other legal requirements in order to ensure the expeditious construction of barriers and roads in the vicinity of the international land border of the United States near the city of Calexico in the state of California.

In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010, Department of Veterans Affairs is publishing this notice to advise the public of the availability of the FY 2015 Service Contract Inventory Analysis Report and FY 2016 proposed analysis. The FY 2015 analysis report discusses the methodology, analysis, and special interest functions studied from the FY 2015 inventory, as well actions, planned and taken, to address any identified weaknesses or challenges. The inventory information is organized by function to show how contracted resources are distributed throughout the agency. The report and inventory were developed in accordance with guidance issued on November 5, 2010, and updated on December 19, 2011, by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https://www.whitehouse.gov/omb/procurement-service-contract-in ventories. The Department of Veterans Affairs has posted the report, inventory, and a summary of the inventory on the Department of Veterans Affairs, Office of Procurement Policy Web site at the following link: www.va.gov/oal/business/pps/scaInventory.asp. This information is also publicly available at www.acquisition.gov/service-contract-inventory, where the government-wide inventory can be filtered to display the Department of Veterans Affairs inventory data.

We are amending the regulations concerning the importation of fruits and vegetables to allow the importation of fresh persimmon with calyxes from Japan into the United States. As a condition of entry, the persimmon must be produced in accordance with a systems approach that includes requirements for orchard certification, orchard pest control, post-harvest safeguards, fruit culling, traceback, and sampling. The persimmons will also have to be accompanied by a phytosanitary certificate with an additional declaration stating that they were produced under, and meet all the components of, the agreed upon systems approach and were inspected and found to be free of quarantine pests. This action will allow the importation of fresh persimmons with calyxes from Japan while continuing to protect against the introduction of plant pests into the United States.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Industrial Automation Systems and Components Thereof Including Control Systems, Controllers, Visualization Hardware, Motion and Motor Control Systems, Networking Equipment, Safety Devices, and Power Supplies, DN 3249; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with the Commission's Noncommercial Educational Station Fundraising for Third-Party Non- Profit Organizations Report and Order's third-party fundraising rules. This document is consistent with the Report and Order, which stated that the Commission would publish a document in the Federal Register announcing the effective date of those rules.

The U.S. Nuclear Regulatory Commission (NRC) is giving notice that by petition dated January 24, 2017, Mr. Paul Gunter on behalf of Beyond Nuclear, and representing numerous public interest groups (collectively, Beyond Nuclear, et al., or petitioners), has requested that the NRC take action with regard to licensees of plants that currently rely on potentially defective safety-related components and potentially falsified quality assurance documentation supplied by AREVA-Le Creusot Forge and its subcontractor, Japan Casting and Forging Corporation. The petitioners' requests are included in the SUPPLEMENTARY INFORMATION section of this document.

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 August 15, 2017 to August 28, 2017. The last biweekly notice was published on August 29, 2017.

The Environmental Protection Agency (EPA) is taking final action to approve the State Implementation Plan (SIP) submission submitted by the Commonwealth of Kentucky, through the Kentucky Division for Air Quality (KDAQ), on September 9, 2016. The changes to the SIP that EPA is taking final action to approve pertain to changes to the Commonwealth's air quality standards for carbon monoxide (CO), lead (Pb), nitrogen dioxide (NO2), ozone, particulate matter (both PM10 and PM2.5), and sulfur dioxide (SO2) to reflect the historical and current National Ambient Air Quality Standards (NAAQS). EPA has determined that the September 9, 2016, SIP revision is consistent with the Clean Air Act (CAA or Act). KDAQ's submission also included additional air quality standards for hydrogen sulfide, fluorides, and odor; however, EPA is not approving these state standards into the SIP.