2018 – Federal Register Recent Federal Regulation Documents

The Office of the Secretary of Defense (OSD) proposes to rescind a system of records, PEGASYS CARDKEY, DWHS D02. This system was used to maintain a list of individuals granted room access to areas of the Pentagon temporarily under the control of Washington Headquarters Services (WHS).

The Advisory Committee on Commercial Remote Sensing (``ACCRES'' or ``the Committee'') will meet October 18, 2018.

The Department of the Treasury, on behalf of itself and the United States Bureau of Engraving and Printing (BEP) and as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to comment on the proposed information collections listed below, in accordance with the Paperwork Reduction Act of 1995.

The National Archives and Records Administration (NARA) proposes to add a system of records to its existing inventory of systems subject to the Privacy Act of 1974. In this notice, we publish NARA 45, Insider Threat Program Records. In addition, we are updating and republishing Appendix B to add the SORN's system manager and update other system manager contact information in the list of system managers and their addresses that apply to all NARA SORNs.

The Department of Commerce (Commerce) is rescinding its administrative review of utility scale wind towers (wind towers) from the Socialist Republic of Vietnam (Vietnam) for the period or review (POR) February 1, 2017, through January 31, 2018, based on the withdrawal of request for review.

The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

The Secretary of the Department of Veterans Affairs (VA) intends to enter into an EUL for the purpose of outleasing Buildings #1, 2, 14, 18, 19, 62, and 64 on approximately 4 acres of underutilized land on the Clement J. Zablocki VA Medical Center, consisting of approximately 101 housing units under different phases (Phase I will consist of 80 housing units in Building #2, and Phase II will consist of approximately 21 housing units in the remaining 6 buildings) to provide permanent supportive housing for veterans. The EUL lessee, National Soldiers Home Residences I, LLC, will finance, design, develop, rehabilitate, manage, maintain, and operate housing for eligible homeless veterans, or veterans at-risk of homelessness, and their families, as well as provide services that guide resident veterans toward attaining long-term self-sufficiency.

FMCSA announces that it is initiating rulemaking action pertaining to the implementation of the Moving Ahead for Progress in the 21st Century Act (MAP-21). MAP-21 raised the financial security amount for brokers to $75,000 and, for the first time, established financial security requirements for freight forwarders. In this ANPRM, the Agency is considering eight separate areas: Group surety bonds/ trust funds, assets readily available, immediate suspension of broker/ freight forwarder operating authority, surety or trust responsibilities in cases of broker/freight forwarder financial failure or insolvency, enforcement authority, entities eligible to provide trust funds for form BMC-85 trust fund filings, Form BMC-84 and BMC-85 trust fund revisions, and household goods (HHG). The Agency seeks comments and data in response to this ANPRM.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Hack-Freight Railroad Bridge across the Hackensack River, mile 3.1, at Jersey City, New Jersey. The deviation is necessary to replace four counterweight sheave assemblies on the west tower of the bridge. This temporary deviation allows the bridge to remain in the closed-to navigation position during the construction period.

The Department of Homeland Security, U.S. Customs and Border Protection 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 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies.

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single-use female condoms, renaming the device to ``single-use internal condom,'' a postamendments class III device (regulated under product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. FDA is also amending the existing device identification for ``female condom,'' a preamendments class III device (product code OBY), by renaming the device ``multiple-use female condom,'' to distinguish it from the ``single-use internal condom.'' This order reclassifies single-use internal condoms from class III to class II and reduces regulatory burden because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome 510(k) before marketing their device.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls.'' The draft guidance, when finalized, establishes guidance for industry and FDA staff on how and when FDA intends to collect, compile, and publicize retail consignees that may have received recalled foods. While FDA intends to focus on recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals (Class I recalls), FDA may also publicize retail consignee lists for other food recalls as described in the draft guidance. FDA's goal is to publicize retail consignee lists for these food recalls where providing this additional information will be of the most use to consumers to help them identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible.

The Pension Benefit Guaranty Corporation (PBGC) received a request from the Alaska Electrical Pension Plan of the Alaska Electrical Pension Fund for approval of a plan amendment providing for special withdrawal liability rules. PBGC published a Notice of Pendency of the Request for Approval of the amendment. PBGC is now advising the public that the agency has approved the requested amendment.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving interviews with entities that submit a Request for Designation (RFD) or pre-RFD, an Investigational New Drug (IND) application or pre-IND request, or a New Drug Application (NDA) or Biologics License Application (BLA) for a combination product to FDA.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the applicants of rare pediatric disease product applications that meet all of the requirements of this program and that are submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY, based on the difference between the average cost incurred by FDA to review of a human drug application designated as priority review in the previous FY and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2019 and outlines the payment procedures for such fees.

In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.