2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) is classifying the negative pressure wound therapy device for reduction of wound complications into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the negative pressure wound therapy device for reduction of wound complications' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend, without revision, the Reporting Provisions Associated with Regulation TT (FR TT; OMB No. 7100-0369).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Development of Anti-Infective Drug Products for the Pediatric Population.'' The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for pediatric patients. The guidance addresses enrollment strategies, extrapolation of efficacy, safety database, and other considerations to help facilitate pediatric anti-infective drug product development. This guidance finalizes the draft guidance of the same title issued on June 30, 2020.

The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, with revision, the Reporting and Recordkeeping Requirements Associated with Regulation W (FR W; OMB No. 7100-0304).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Specifically, this draft guidance addresses FDA's current recommendations regarding trial design, safety, and efficacy considerations for CRSwNP clinical trials.

The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Recordkeeping Provisions Associated with the Guidance on Sound Incentive Compensation Policies (FR 4027; OMB No. 7100-0327).

The White House Office of Science and Technology Policy (OSTP) is organizing a series of virtual listening sessions to hear about ideas, issues, and potential solutions related to the problem of orbital debris from members of the public who have an interest or stake in orbital debris research and development. Perspectives gathered during the virtual listening sessions will inform the National Science and Technology Council (NSTC) Orbital Debris Research and Development Interagency Working Group (ODRAD IWG) as it develops a government-wide orbital debris implementation plan, examining R&D activities as well as other considerations such as policy levers, international engagements, and other ideas outside of R&D solutions that may help build a cohesive implementation strategy. The implementation plan is a continuation of work done for the National Orbital Debris Research and Development Plan (January 2021), which was a response to Space Policy Directive3 (June 2018), directing the United States to lead the management of traffic and mitigate the effects of debris in space.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance request for comment to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This request helps to ensure that: Requested data can be provided in the desired format; reporting burden (time and financial resources) is minimized; collection instruments are clearly understood; and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Health Standards for Diesel Particulate Matter Exposure (Underground Metal and Nonmetal Mines).

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance request for comment to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This request helps to ensure that: Requested data can be provided in the desired format; reporting burden (time and financial resources) is minimized; collection instruments are clearly understood; and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Petitions for Modification of Mandatory Safety Standards.

The Department of Labor (DOL) is submitting this Mine Safety and Health Administration (MSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

Notice is hereby given that the U.S. International Trade Commission has determined to review in part the Administrative Law Judge's (``ALJ'') final initial determination (``ID''), issued on October 7, 2021, finding no violation of section 337 in the above- referenced investigation as to three asserted patents. The Commission requests briefing from the parties on certain issues under review. The Commission also requests briefing from the parties, interested government agencies, and other interested persons on remedy, the public interest, and bonding, as indicated in this notice.

Notice is hereby given that the U.S. International Trade Commission (``Commission'') has determined not to review an initial determination (``ID'') (Order No. 46) of the presiding administrative law judge (``ALJ''), granting respondent Bio-Rad Laboratories, Inc.'s motion for return of the bond it posted during the period of Presidential Review.

Notice is hereby given that the U.S. International Trade Commission has determined to review in part a final initial determination (``FID'') of the presiding administrative law judge (``ALJ'') finding a violation of section 337 of the Tariff Act of 1930, as amended. The Commission requests briefing from the parties on certain issues under review, as set forth in this notice. The Commission also requests briefing from the parties, interested persons, and government agencies on the issues of remedy, the public interest, and bonding. The Commission has further determined to extend the target date until February 3, 2022.

FRA is issuing this notice to advise the public that it is issuing a Final General Conformity Determination (FCD) for the Burbank to Los Angeles Section of the California High-Speed Rail (HSR) System.

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 the Nevada Advisory Committee (Committee) will hold a meeting via web conference on Friday, January 28, 2022, from 3:00 p.m. to 5:00 p.m. Pacific Time. The purpose of the meeting is to hear testimony from stakeholders who are involved with the planning, delivery, and use of remote learning for Nevada students in K-12 schools. Specifically, the Committee is interested in the progress being made to implement the Committee's report recommendations in The Impact of Remote Learning on Education Equity in Nevada.

We, the U.S. Fish and Wildlife Service (Service), invite the public to comment on foreign or native species for which the Service has jurisdiction under the Marine Mammal Protection Act (MMPA) and foreign bird species covered under the Wild Bird Conservation Act (WBCA). With some exceptions, the MMPA and WBCA prohibit activities with listed species unless Federal authorization is issued that allows such activities. These Acts also require that we invite public comment before issuing permits for any activity they otherwise prohibit with respect to any species.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the document entitled ``Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance of Industry,'' published in the Federal Register on September 30, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.

The Department of Homeland Security (DHS), on behalf of the Interagency Task Force on the Reunification of Families (Task Force), is seeking comments from the public on recommendations for ways to minimize the separation of migrant parents and legal guardians and children entering the United States, consistent with the law. This input will help in the drafting of a report required by the Executive order titled ``Establishment of Interagency Task Force on the Reunification of Families.''

EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs). The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.