October 2022 – Federal Register Recent Federal Regulation Documents

The seventh iteration of the Prescription Drug User Fee Amendments (PDUFA VII) included as part of the FDA User Fee Reauthorization Act of 2022 highlights the goal of advancing and facilitating the development and timely approval of drugs and biological products for rare diseases, including rare diseases in children. The Food and Drug Administration (FDA or Agency) is announcing the Rare Disease Endpoint Advancement Pilot Meeting Program (RDEA Pilot Program) established under the seventh iteration of PDUFA that affords sponsors who are admitted into the RDEA Pilot Program additional engagement opportunities with the Agency to discuss efficacy endpoint development in rare disease drug and biological product development programs. Meetings under the program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years (FYs) 2023 to 2027. For each sponsor whose RDEA program proposal (RDEA proposal or proposal) is admitted into the program, up to four meetings that will provide an opportunity for medical product developers to discuss rare disease endpoint development will be held between the sponsor and CDER or CBER. To promote innovation and evolving science, novel endpoints developed through the RDEA Pilot Program may be presented by FDA (e.g., in a guidance or public workshop or on a public-facing website) as case studies, including novel endpoints for drugs that have not yet been approved or biological products that have not yet been licensed by FDA for a given indication.

In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (CFPB or Bureau) requests the extension of the Office of Management and Budget's (OMB's) approval of the existing information collection titled ``Survey Screening Question List.''

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Generator Standards Applicable to Laboratories Owned by Eligible Academic Entities (EPA ICR Number 2317.04, OMB Control Number 2050-0204) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2022. Public comments were previously requested via the Federal Register on May 2, 2022 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Ethnicity, Race, Gender and Disability Form (EPA ICR Number 2717.01, OMB Control Number 2030-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the Federal Register on March 2, 2022, and another notice was published on April 21, 2022 to extend the public comment period to allow for a 60-day comment period on supplemental documents that were added to the docket. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct, or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

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 briefing of the Massachusetts Advisory Committee to the Commission will convene via web conference on Tuesday, November 1, 2022, at 12:00 p.m. (ET). The purpose of the briefing is to hear from additional panelists on civil asset forfeiture. The public will have an opportunity to make comments towards the conclusion of the briefing. Meeting Date: Tuesday, November 1, 2022; at 12:00 p.m. (ET). Zoom Link (audio/video): https://tinyurl.com/3vtr9tj7. If Phone Only, Dial: 1-800-360-9505; Meeting ID: 161 046 1872#.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 is a new information collection request soliciting comments on the information collection requirements relating to the Office of Healthcare Information and Counseling (OHIC) Profiles project at ACL.

The Transportation Security Administration (TSA) will hold a public meeting of the Aviation Security Advisory Committee (ASAC) on December 1, 2022. Members of the ASAC will meet in person at the TSA Headquarters. A link to virtually participate in the meeting will be available to members of the public as discussed below under SUPPLEMENTARY INFORMATION/Public Participation. An agenda for the meeting can also be found under SUPPLEMENTARY INFORMATION.

The Commission will consider a Further Notice of Proposed Rulemaking that would ensure continued support for mobile carriers and extend the support phase down for incumbent fixed broadband providers in Puerto Rico and the U.S. Virgin Islands to enhance their networks' reliability and resiliency in the face of hurricanes and other natural disasters. 2.................. Wireless Tele- Title: Considering 12.7 GHz Communications and Band for Next-Generation Office of Engineering Wireless Services (GN & Technology. Docket No. 22-352). Summary: The Commission will consider a Notice of Inquiry to seek information on the current use of the 12.7-13.25 GHz band, ways to encourage more efficient and intensive use of the band, and whether the band is suitable for mobile broadband or other expanded use. The Commission will also consider an Order to extend the temporary freeze on applications in the 12.7 GHz band. 3.................. Wireline Competition.. Title: Caller ID Authentication on Non-IP Networks (WC Docket No. 17- 97). Summary: The Commission will consider a Notice of Inquiry launching a broad inquiry on caller ID authentication technology for non-Internet Protocol networks. 4.................. Public Safety & Title: Improving the Homeland Security. Security of the National Alert and Warning Systems (PS Docket No. 22-329); Amendment of Part 11 of the Commission's Rules Regarding the Emergency Alert System (PS Docket No. 15-94); Wireless Emergency Alerts (PS Docket No. 15-91). Summary: The Commission will consider a Notice of Proposed Rulemaking to strengthen the operational readiness of the Emergency Alert System and Wireless Emergency Alerts, including by reducing the vulnerability of these systems to cyberattacks. 5.................. Media................. Title: Restricted Adjudicatory Matter. Summary: The Commission will consider a restricted adjudicatory matter.

The Food and Drug Administration (FDA) is postponing the joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee scheduled for November 18, 2022. Future meeting dates will be announced in the Federal Register.

The Food and Drug Administration (FDA or we) is 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.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR),Request for Contractor Access to Toxic Substances Control Act Confidential Business Information (CBI) (EPA ICR Number 1250.12; OMB Control Number 2070-0075) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR which is currently approved through October 31, 2022. Public comments were previously requested via the Federal Register on January 24, 2022 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Iron and Steel Foundries Area Sources (EPA ICR Number 2267.08, OMB Control Number 2060-0605), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through September 31, 2023. Public comments were previously requested, via the Federal Register, on February 8, 2021 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The Department of Homeland Security, U.S. Customs and Border Protection will be 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 information collection is published in the Federal Register to obtain comments from the public and affected agencies.

The Department of Homeland Security, U.S. Customs and Border Protection will be 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 information collection is published in the Federal Register to obtain comments from the public and affected agencies.

In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.

The purpose of this notice is to inform the public and interested State and local government officials of the filing of Plats of Survey in Nevada.