December 2, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics.'' This guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biological product. The guidance describes important principles for designing, conducting, and reporting the results from an adaptive clinical trial. This guidance finalizes the draft guidance entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics'' issued in October 2018. FDA is also 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.

In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service (Service), are proposing to renew an information collection.

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, 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 information collection associated with the requirement for submission of information on pediatric subpopulations that suffer from a disease or condition that a device is intended to treat, diagnose, or cure.

This document cancels a public hearing on proposed regulations under sections 1291, 1297, and 1298 of the Internal Revenue Code (``Code'') regarding the determination of ownership in a passive foreign investment company within the meaning of section 1297(a) (``PFIC'') and the treatment of certain income received or accrued by a foreign corporation and assets held by a foreign corporation for purposes of section 1297.

This notice amends the notice of a major disaster declaration for State of Oregon (FEMA-4432-DR), dated May 2, 2019, and related determinations.

This notice amends the notice of a major disaster declaration for State of Illinois (FEMA-4461-DR), dated September 19, 2019, and related determinations.

This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-flood-insurance-program-community-statu s-book.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

In accordance with the Paperwork Reduction Act of 1995, the USDA Forest Service and certain Department of Interior agencies are seeking comments from all interested individuals and organizations on the extension of a currently approved information collection, Youth Conservation Corps Application and Medical History.

The Commission hereby gives notice that it has instituted a review pursuant to the Tariff Act of 1930 (``the Act''), as amended, to determine whether revocation of the antidumping duty order on electrolytic manganese dioxide from China would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.

The Commission hereby gives notice that it has instituted reviews pursuant to the Tariff Act of 1930 (``the Act''), as amended, to determine whether revocation of the antidumping and countervailing duty orders on carbon and certain alloy steel wire rod (``wire rod'') from China would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.

This proposal invites comments on adding the State of Missouri as a primary peanut-producing State under the Peanut Promotion, Research, and Information Order (Order). The Order is administered by the National Peanut Board (Board) with oversight by the U.S. Department of Agriculture (USDA). This proposal would also add a producer member and alternate member to the Board to represent the State of Missouri. The Board recommended this action to ensure that the Board's representation reflects changes in the geographical distribution of the production of peanuts.

Through this final rule, NMFS is implementing allowable catch levels, an overfishing limit, an allowable biological catch, and an annual catch limit for Pacific mackerel in the U.S. exclusive economic zone off the West Coast (California, Oregon and Washington) for the fishing seasons 2019-2020 and 2020-2021, pursuant to the Coastal Pelagic Species Fishery Management Plan. The harvest guideline and annual catch target for the 2019-2020 fishing season are 11,109 metric tons (mt) and 10,109 mt, respectively. The harvest guideline and annual catch target for the 2020-2021 fishing season are 7,950 mt and 6,950 mt, respectively. If the fishery attains the annual catch target in either fishing season, the directed fishery will close, reserving the 1,000-mt difference between the harvest guideline and annual catch target as a set-aside for incidental landings in other Coastal Pelagic Species fisheries and other sources of mortality. This rule is intended to conserve and manage the Pacific mackerel stock off the U.S. West Coast.

This action contains a correction to the final rule published on May 10, 2019, to establish the harvest specifications and management measures for the 2019 Pacific whiting fishery under the authority of the Pacific Coast Groundfish Fishery Management Plan, the Magnuson- Stevens Fishery Conservation and Management Act, and the Pacific Whiting Act of 2006. This action restores language inadvertently omitted from the final rule that explains that NMFS will consider Chinook salmon bycatch and bycatch rates prior to reapportionment of the tribal Pacific whiting allocation. These corrections are necessary to restore this language so that the regulations accurately implement the National Marine Fisheries Service's intent, as described in the preamble to the final rule.

The Environmental Protection Agency (EPA) is proposing to update a portion of the Outer Continental Shelf (OCS) Air Regulations. Requirements applying to OCS sources located within 25 miles of states' seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (COA), as mandated by the Clean Air Act (CAA). The portion of the OCS air regulations that is being updated pertains to the requirements for OCS sources subject to requirements of the State of Alaska. The State of Alaska's requirements discussed in this document, and listed in the appendix to the Federal OCS air regulations, are proposed to be incorporated into the compilation of state provisions that is incorporated by reference.

The FAA is revising an earlier proposal for all The Boeing Company Model 757 airplanes. This action revises the notice of proposed rulemaking (NPRM) by reducing the compliance time for certain airplane configurations. The FAA is proposing this airworthiness directive (AD) to address the unsafe condition on these products. Since these actions would impose an additional burden over those in the NPRM, the FAA is reopening the comment period to allow the public the chance to comment on these changes.

The NCUA Board (Board) is updating and revising its Interpretive Ruling and Policy Statement (IRPS) regarding statutory prohibitions imposed by Section 205(d) of the Federal Credit Union Act (FCU Act). Section 205(d) prohibits, except with the prior written consent of the Board, any person who has been convicted of any criminal offense involving dishonesty or breach of trust, or who has entered into a pretrial diversion or similar program in connection with a prosecution for such offense, from participating in the affairs of an insured credit union. The Board is rescinding current IRPS 08-1 and issuing a revised and updated IRPS to reduce regulatory burden. The Board is amending and expanding the current de minimis exception to reduce the scope and number of offenses that will require an application to the Board. Specifically, the final IRPS will not require an application for convictions involving insufficient funds checks of aggregate moderate value, small dollar simple theft, false identification, simple drug possession, and isolated minor offenses committed by covered persons as young adults.