July 15, 2020 – Federal Register Recent Federal Regulation Documents

The North Pacific Fishery Management Council submitted Amendment 50 to the Fishery Management Plan (FMP) for Bering Sea/ Aleutian Islands (BSAI) King and Tanner Crabs (Crab FMP) (Amendment 50), to the Secretary of Commerce for review. If approved, Amendment 50 would add a new rebuilding plan for St. Matthew blue king crab (SMBKC) to the Crab FMP. The objective of this amendment is to rebuild the SMBKC stock. In order to comply with provisions of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), this action is necessary to implement a rebuilding plan prior to the start of the 2020/2021 fishing season. Amendment 50 is intended to promote the goals and objectives of the Magnuson-Stevens Act, the Crab FMP, and other applicable laws.

The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), to withdraw approval of the new drug application (NDA) for Vioform-Hydrocortisone Cream, Ointment, and Lotion containing Iodochlorhydroxyquin and Hydrocortisone (Vioform), is the final decision of the Commissioner by operation of law. Several parties to the hearing, including the NDA holder and identical, related, or similar (IRS) product manufacturers, and a non-party participant timely filed exceptions to the ALJ's Initial Decision. FDA recently requested that the current owner of the NDA application, the IRS product manufacturers, and the non-party participant that had timely filed exceptions, or their successors-in-interest, affirm within a specific timeframe their interest in pursuing their appeals of the ALJ's Initial Decision. The NDA holder responded within the timeframe and withdrew its appeal. No other appellants that received actual notice of the Agency's request responded within the timeframe. Accordingly, FDA now deems any exceptions filed by appellants that received notice of the Agency's request to be withdrawn. FDA is, however, offering an opportunity to other IRS product manufacturers, or successors-in- interest, that submitted exceptions to the ALJ's Initial Decision and did not receive notice of FDA's request, to affirm their desire to pursue the appeal. The ALJ's Initial Decision is the final decision of the Commissioner by operation of law; however, if FDA receives a valid request to affirm the appeal, as described in this notice, we will withdraw this notice.

Effective July 6, 2018, the U.S. Trade Representative imposed additional duties on goods of China with an annual trade value of approximately $34 billion as part of the action in the Section 301 investigation of China's acts, policies, and practices related to technology transfer, intellectual property, and innovation. The U.S. Trade Representative's determination included a decision to establish a product exclusion process, which was initiated in July 2018. Stakeholders submitted requests for the exclusion of specific products and the U.S. Trade Representative has issued determinations to grant exclusion requests. This notice announces the U.S. Trade Representative's determination to make a technical amendment to a previously granted exclusion.

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.

The Department of Commerce (Commerce) is rescinding the administrative review of the countervailing duty (CVD) order on cold- drawn mechanical tubing of carbon and alloy steel (CDMT) from the People's Republic of China (China) for the period of review (POR) January 1, 2019, through December 31, 2019, based on the timely withdrawal of the request for review.

The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-656 and 731-TA-1533 (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 metal lockers from China, provided for in subheadings 9403.20.00 (9403.20.0078) and 9403.90.80 (9403.90.8041) 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 Government of China. Unless the Department of Commerce (``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 August 24, 2020. The Commission's views must be transmitted to Commerce within five business days thereafter, or by August 31, 2020.

The Department of Justice, Federal Bureau of Investigation's (FBI's) Criminal Justice Information Services Division is 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 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 barium carbonate from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Delaware Advisory Committee to the Commission will convene by conference call, on Wednesday, August 5, 2020 at 1:00 p.m. (EDT). The purpose of the meeting is for project planning and selection of additional Committee officers.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the New Jersey Advisory Committee to the Commission will convene by conference call, on Friday, August 21, 2020 at 1:00 p.m. (EDT). The purpose of the meeting is to receive updates from the Forfeiture and Licensing Workgroups about suggestions for planning the Committee's briefing to examine its civil rights project on the collateral consequences that a criminal record has on criminal asset forfeitures and occupational licensing.

The OCC is seeking nominations for members of the Mutual Savings Association Advisory Committee (MSAAC) and the Minority Depository Institutions Advisory Committee (MDIAC). The MSAAC and the MDIAC assist the OCC in assessing the needs and challenges facing mutual savings associations and minority depository institutions, respectively. The OCC is seeking nominations of individuals who are officers and/or directors of federal mutual savings associations, or officers and/or directors of federal stock savings associations that are part of a mutual holding company structure, to be considered for selection as MSAAC members. The OCC also is seeking nominations of individuals who are officers and/or directors of OCC-regulated minority depository institutions, or officers and/or directors of other OCC- regulated depository institutions with a commitment to supporting minority depository institutions, to be considered for selection as MDIAC members.

The OCC has determined that the renewal of the charter of the OCC Minority Depository Institutions Advisory Committee (MDIAC) is necessary and in the public interest. The OCC hereby gives notice of the renewal of the charter.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered tropical diseases for purposes of obtaining PRVs and provides for Agency expansion of that list to include other diseases that satisfy the definition of ``tropical diseases'' as set forth in the FD&C Act. The Agency has determined that brucellosis satisfies this definition and is therefore adding it to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain drug or biological product applications for the prevention or treatment of brucellosis may be eligible to receive a PRV if such applications are approved by FDA.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered tropical diseases for purposes of obtaining PRVs and provides for Agency expansion of that list to include other diseases that satisfy the definition of ``tropical diseases'' eligible for PRVs as set forth in the FD&C Act. The Agency has determined that two foodborne trematode infections, opisthorchiasis and paragonimiasis, satisfy this definition, and is therefore adding them to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain drug or biological product applications for the prevention or treatment of opisthorchiasis or paragonimiasis infections may be eligible to receive a PRV if such applications are approved by FDA.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Providing Regulatory Submissions for Medical Devices in Electronic FormatSubmissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.'' Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA Reauthorization Act of 2017 (FDARA) require that certain pre- submissions and submissions for devices be submitted in electronic format specified by FDA beginning on such date as specified in final guidance. It also mandates that FDA issue draft guidance not later than October 1, 2019, and a final guidance not later than 1 year after the close of the public comment period, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter from the Secretary of Health and Human Services to Congress, FDA committed to developing electronic submission templates, and issuing a draft guidance on the topic. No later than 12 months after the close of the public comment period, the Agency will issue a final guidance. This guidance is intended to satisfy the final guidance documents referenced in the FDA&C Act and the MDUFA IV Commitment Letter.

The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), that Vasodilan containing Isoxsuprine Hydrochloride had not been shown to be supported by substantial evidence consisting of adequate and well-controlled studies to be effective for treating symptoms relating to senile dementia of the Alzheimer type (SDAT) and multiple infarct dementia and peripheral vascular disease, is the final decision of the Commissioner of Food and Drugs (the Commissioner).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #266 entitled ``Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs.'' The draft guidance, if finalized, will describe FDA's current thinking with respect to assisting sponsors in incorporating real-world data and real-world evidence (including ongoing surveillance activities, observational studies, and registry data) into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #268 entitled ``Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs.'' The draft guidance, if finalized, will describe FDA's current thinking with respect to assisting sponsors in incorporating complex adaptive and other novel investigation designs into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).