March 2, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``E18 Genomic Sampling and Management of Genomic Data.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance focuses on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data in clinical studies. The guidance is intended to provide harmonized principles of genomic sampling and of management of genomic data in clinical studies to foster interactions amongst stakeholders, including drug developers, investigators, and regulators; and to encourage genomic research within clinical studies.

In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625-0011, Applications for Private Aids to Navigation and for Class I Private Aids to Navigation on Artificial Islands and Fixed Structures. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.

The OCC announces a meeting of the Mutual Savings Association Advisory Committee (MSAAC).

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0005, Application and Permit to Handle Hazardous Material; without change. Our ICR describe the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0012, Certificate of Discharge to Merchant Mariner; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Kobe, Japan, scheduled for June 4 through 7, 2018. The topics to be addressed at the public meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly Meeting in Kobe.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Northwestern Pacific (SMART) railroad bridge across the Petaluma River, mile 12.4, at Haystack Landing (Petaluma), CA. This deviation will test a change to the drawbridge operation schedule to determine whether a permanent change to the schedule is appropriate. This test deviation will modify the existing regulation to add an advance notification requirement for obtaining bridge openings.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Route 280 Bridge across the Passaic River, mile 5.8, at Harrison, New Jersey. The deviation is necessary to perform work on the switch gear power source of the bridge. This deviation allows the bridge to undergo necessary maintenance for Route 21 interchange improvements. This deviation allows the bridge to remain closed during the maintenance period.

The National Park Service proposes to allow individuals to carry or possess a bow or crossbow within the National Park System when accessing otherwise inaccessible lands or waters contiguous to a park area when other means of access are otherwise impracticable or impossible.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Meadowbrook State Parkway Bridge across the Sloop Channel, mile 12.8, at Hempstead, New York. This temporary deviation is necessary to allow the bridge to remain in the closed-to-navigation position to facilitate the machinery rehabilitation and spanlock replacement of the bridge. This deviation allows the bridge to remain in the closed position.

The Department of Veterans Affairs (VA) is providing public notice of inflationary adjustments to the maximum civil monetary penalties assessed or enforced by VA, as implemented by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, for calendar year 2018. VA may impose civil monetary penalties for false loan guaranty certifications. Also, VA may impose civil monetary penalties for fraudulent claims or written statements made in connection with VA programs generally. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, sets forth a formula that increases the maximum statutory amounts for civil monetary penalties and directs VA to give public notice of the new maximum amounts by regulation. Accordingly, VA is providing notice of the calendar year 2018 inflationary adjustments that increase maximum civil monetary penalties from $21,916 to $22,363 for false loan guaranty certifications and from $10,957 to $11,181 for fraudulent claims or written statements made in connection with VA programs generally.

NARA proposes to request an extension from the Office of Management and Budget (OMB) of a currently approved information collection used by the public and other Federal agencies to use its official seal(s) and/or logo(s). We invite you to comment on this proposed information collection pursuant to the Paperwork Reduction Act of 1995.

The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, ``Agreement and Undertaking,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.

The Internal Revenue Service, 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 continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning performance and quality for small wind energy property.

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 757 airplanes. This proposed AD was prompted by an evaluation by the design approval holder (DAH) indicating that the longitudinal lap splices of the fuselage skin are subject to widespread fatigue damage (WFD). This proposed AD would require repetitive inspections of the longitudinal lap splices of the fuselage skin for cracking and protruding fasteners, and applicable corrective actions. We are proposing this AD to address the unsafe condition on these products.

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 Commission 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.

The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons and vessels that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons and these vessels are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Land Management (BLM), are proposing to renew an information collection with revisions.

In accordance with the Paperwork Reduction Act of 1995, we, the Federal Consulting Group are proposing to renew an information collection.

This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that model year (MY) 2007 Jeep Wrangler Multipurpose Passenger Vehicles (MPV) manufactured before September 1, 2007, that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS) are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards, specifically the U.S.-certified version of the 2007 Jeep Wrangler MPV manufactured before September 1, 2007, and they are capable of being readily altered to conform to the standards.