October 11, 2022 – Federal Register Recent Federal Regulation Documents

In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Science Advisory Committee. The meeting will be held specifically to discuss reporting under the Government Performance and Results Modernization Act (GPRAMA).

The National Credit Union Administration (NCUA) 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 Federal Emergency Management Agency's National Advisory Council (NAC) will meet on October 25-27, 2022. The meeting will be open to the public through virtual means.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will convene the 75th full council meeting virtually on Monday, October 17, 2022 from approximately 12:00-2:00 p.m. (ET). The meeting will be open to the public and there will be a public comment session; pre- registration is required to provide public comment. To pre-register to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Monday, October 10, 2022. There is also an option to submit written statement by emailing PACHA@hhs.gov by close of business Monday, October 24, 2022. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/federal-response/pacha/about-pacha prior to the meeting.

The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a supplemental new drug application (sNDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

The Environmental Protection Agency (EPA) is hosting two identical public meetings to discuss and solicit input on environmental justice considerations related to the development of the proposed Lead and Copper Rule Improvements (LCRI) national primary drinking water regulation (NPDWR) under the Safe Drinking Water Act (SDWA). In the context of developing this proposed regulation, environmental justice considerations include the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies with a particular focus on unique challenges faced by communities disproportionately burdened by environmental harms and risks. EPA is holding these meetings to share information and provide an opportunity for communities to offer input on environmental justice considerations for the development of the proposed LCRI. Information on how to register and request to speak during one of the meetings is detailed in the SUPPLEMENTARY INFORMATION section of this announcement.

On January 5, 2021, the United States Court of Appeals for the Tenth Circuit granted the Environmental Protection Agency's (EPA) motion for a voluntary remand without vacatur of two parts of an EPA 2020 final rule approving Colorado's infrastructure state implementation plan (SIP) submission for the 2015 8-hour ozone national ambient air quality standards (NAAQS) (2020 final rule). In this document, EPA is taking final action to approve those two remanded parts of the 2020 final rule. First, EPA is finalizing our conclusion that Colorado's infrastructure SIP submission meets the State's good neighbor obligations under Clean Air Act (CAA) section 110(a)(2)(D)(i)(I). Lastly, EPA is also finalizing our conclusion that Colorado's infrastructure SIP submission provided ``necessary assurances'' of the State's authority to regulate agricultural sources under CAA section 110(a)(2)(E)(i). EPA is taking this action pursuant to the CAA.

This regulation establishes tolerances for residues of methoxyfenozide in or on multiple crops detailed later in this document. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

The FAA is superseding Airworthiness Directive (AD) 2021-10-10 for all Airbus Helicopters Model SA330J helicopters. AD 2021-10-10 required repetitively inspecting the main gearbox (MGB) particle detector and the MGB bottom housing (oil sump) for metal particles, analyzing any metal particles that are found, and replacing the MGB if necessary. Since the FAA issued AD 2021-10-10, additional review concluded that installing an improved planet gear assembly is necessary. This AD continues to require repetitively inspecting the MGB particle detector and the MGB bottom housing (oil sump) for metal particles, and analyzing any metal particles that are found, and also requires replacing the planet gear assembly and repetitively inspecting and establishing an airworthiness limitation for that assembly as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.

Hybrid Pharma has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.