2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Q13 Continuous Manufacturing of Drug Substances and Drug Products.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. The draft guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Department of Justice, Office of Justice Programs, submitted a 60-day notice for publishing in the Federal Register on September 27, 2021 soliciting comments to an information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This notice was incorrectly submitted. This information collection request will be discontinued as no immediate data collection is planned.

The Trinity County Resource Advisory Committee (RAC) will meet virtually via Microsoft Teams. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act, as well as make recommendations on recreation fee proposals for sites on the Shasta-Trinity National Forest within Trinity County, consistent with the Federal Lands Recreation Enhancement Act. RAC information and virtual meeting information can be found at the following website: https://www.fs.usda.gov/main/stnf/workingtogether/advisorycom mittees.

This is a notice of the Presidential declaration of a major disaster for the State of California (FEMA-4619-DR), dated September 12, 2021, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the Commonwealth of Pennsylvania (FEMA-4618-DR), dated September 10, 2021, and related determinations.

This notice amends the notice of a major disaster declaration for the State of New York (FEMA-4615-DR), dated September 5, 2021, and related determinations.

This notice amends the notice of a major disaster declaration for the State of New York (FEMA-4615-DR), dated September 5, 2021, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the State of New York (FEMA-4615-DR), dated September 5, 2021, and related determinations.

This notice amends the notice of a major disaster declaration for the State of New Jersey (FEMA-4614-DR), dated September 5, 2021, and related determinations.

The Shasta County Resource Advisory Committee (RAC) will meet virtually via Microsoft Teams. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act, as well as make recommendations on recreation fee proposals for sites on the Shasta-Trinity National Forest within Shasta County. RAC information can be found at the following website: https://www.fs.usda.gov/main/ stnf/workingtogether/advisorycommittees.

This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4586-DR), dated February 19, 2021, and related determinations.

This notice amends the notice of a major disaster declaration for State of Alaska (FEMA-4585-DR), dated February 17, 2021, and related determinations.

This notice amends the notice of a major disaster declaration for State of Washington (FEMA-4584-DR), dated February 4, 2021, and related determinations.

This notice amends the notice of a major disaster declaration for State of Alabama (FEMA-4573-DR), dated December 10, 2020, and related determinations.