October 20, 2023 – Federal Register Recent Federal Regulation Documents

In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a new information collection request (ICR).

Notice is hereby given that on July 7, 2023, the presiding administrative law judge (``ALJ'') issued a combined final initial determination (``ID'') finding a violation of section 337 and recommended determination (``RD'') on remedy and bonding in the above- captioned investigation. The Commission has determined to review the final ID in part. The Commission requests written submissions from the parties on the issues under review and submissions from the parties, interested government agencies, and interested persons on the issues of remedy, the public interest, and bonding, under the schedule set forth below.

Under the Johnson-O'Malley (JOM) Act of 1934, as amended by the JOM Supplemental Indian Education Program Modernization Act of 2018, the Bureau of Indian Education (BIE) is publishing a Final Report that describes the initial determination of the number of eligible Indian students served or potentially served by each eligible entity, the data used for BIE to make such determination, feedback gained during the comment period, and justification for not applying feedback gained during the comment period.

The Orphaned Wells Program Office (OWPO) invites public comment to help inform its efforts in determining how to best structure the Regulatory Improvement Grant (RIG) program, pursuant to section 40601 of the Infrastructure Investment and Jobs Act, also referred to as the Bipartisan Infrastructure Law (Act).

In compliance with the Paperwork Reduction Act of 1995, the Defense Health Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

In accordance with section 113(g) of the Clean Air Act, as amended (``CAA'' or ``the Act''), the Environmental Protection Agency (``EPA'' or ``the Agency'') is providing notice of a proposed consent decree in California Communities Against Toxics v. Regan, No. 1:22-cv- 1457 (D.D.C.). On May 24, 2022, California Communities Against Toxics, Clean Air Council, Clean Power Lake County, Delaware Concerned Residents for Environmental Justice, Greater-Birmingham Alliance to Stop Pollution, Kentucky Resources Council, New Castle Prevention Coalition, United Congregations of Metro-East, and Sierra Club (collectively, ``Plaintiffs'') filed a complaint in the United States District Court for the District of Columbia alleging that EPA failed to perform its non-discretionary duty to ``review, and revise as necessary'' the National Emission Standards for Hazardous Air Pollutants (``NESHAP'') for Chemical Manufacturing Area Sources (``CMAS''), at least every 8 years. The proposed consent decree would establish deadlines for the EPA Administrator (``Administrator'') to sign a notice of proposed rulemaking and a final rule for this action.

In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) announces the availability of the Hult Reservoir and Dam Safety Draft Environmental Impact Statement (EIS).

The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995 requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

In compliance with the Paperwork Reduction Act of 1995, the Defense Health Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

FEMA gives notice that the minimum Project Worksheet Amount under the Public Assistance program for disasters and emergencies declared on or after October 1, 2023, will be increased.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Benefit- Risk Assessment for Human Drug and Biological Products.'' FDA has developed this guidance document in accordance with goals associated with the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) under Title I of the FDA Reauthorization Act of 2017 and requirements under the 21st Century Cures Act. The intent of this guidance is to provide drug sponsors and other stakeholders with better clarity on how considerations about a drug's benefits, risks, and risk management options factor into FDA's pre- and postmarket regulatory decisions about new drug applications (NDAs) or biologics license applications (BLAs). This guidance finalizes the draft guidance of the same title issued in September 2021.

Under the provisions of the Paperwork Reduction Act, agencies are required to publish a Notice in the Federal Register notifying the public that the agency is renewing an existing information collection for OMB review and approval and requests public review and comment on the submission. The agencies received no comments in response to the sixty (60) day notice. The purpose of this notice is to allow an additional thirty (30) days for public comments to be submitted. Comments are being solicited on the need for the information; the accuracy of the burden estimate; the quality, practical utility, and clarity of the information to be collected; and ways to minimize reporting the burden, including automated collected techniques and uses of other forms of technology.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry.'' The guidance document describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA's Center for Biologics Evaluation and Research (CBER) designed to identify Voluntary Consensus Standards (VCS) that might be used in the preparation and evaluation of submissions for Regenerative Medicine Therapy (RMT) products regulated by CBER when such standards are appropriate. The use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. This program is modeled after the formal standards and conformity assessment program (S-CAP) for medical devices where the term ``recognize'' refers to FDA's formal identification of a standard after the determination that the standard is appropriate to meet relevant requirements as defined by law. CBER encourages the use of appropriate standards in the development of CBER- regulated products. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2022.

In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This action proposes to establish Class E airspace extending upward from 700 feet above the surface at Antone Ranch Airport, Mitchell, OR, in support of the airport's forthcoming transition from visual flight rules (VFR) to instrument flight rules (IFR) operations.

The Commission announces its disposition of a Petition for Rulemaking. The Petition asked the Commission to modify its regulation on written comments on advisory opinion requests to provide time for the public to comment on drafts of advisory opinions before the Commission votes on the drafts. For the reasons described in detail below, the Commission is not initiating a rulemaking at this time.

The Commission announces its disposition of a Petition for Rulemaking filed on December 4, 2018, by Extreme Reach. The Petition asks the Commission to amend its regulation on the size of letters in disclaimers in certain television advertisements such that the required letter size for advertisements broadcast in high definition would be reduced. Because changing the Commission's regulations as requested in the Petition would create a direct conflict with regulations of the Federal Communications Commission, the Commission is not initiating a rulemaking at this time.

This is a notice of the Presidential declaration of an emergency for the Commonwealth of Massachusetts (FEMA-3599-EM), dated September 15, 2023, and related determinations.

This is a notice of the Presidential declaration of an emergency for the State of Florida (FEMA-3596-EM), dated August 28, 2023, and related determinations.

NMFS announces its intent to issue exempted fishing permits (EFPs), scientific research permits (SRPs), display permits, letters of acknowledgment (LOAs), and shark research fishery permits for Atlantic highly migratory species (HMS) in 2024. EFPs and related permits would authorize collection of a limited number of HMS, including tunas, swordfish, billfishes, and sharks, from Federal waters in the Atlantic Ocean, Gulf of Mexico, and Caribbean Sea for the purposes of scientific research, data collection, the investigation of bycatch, and public display, among other things. LOAs acknowledge that scientific research activity aboard a scientific research vessel is being conducted. Generally, EFPs and related permits would be valid from the date of issuance through December 31, 2024, unless otherwise specified in the permit, subject to the terms and conditions of individual permits.

FEMA gives notice that the statewide per capita impact indicator under the Public Assistance program for disasters with an incident start date on or after October 1, 2023, will be increased.

FEMA gives notice of an adjustment to the threshold for Small Project subgrants made to State, Tribal, and local governments and private nonprofit facilities for disasters declared on or after October 1, 2023.