Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAURISMO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human drug product.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed revision for the information collection requirements related to the National Survey of Older Americans Act Participants.

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 80th full council meeting on Wednesday, March 27-Thursday, March 28, 2024. The meeting will be open to the public and there will be a public comment session during the meeting; 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, March 18, 2024. If you decide you would like to provide public comment but do not pre- register, you may submit your written statement by emailing PACHA@hhs.gov by close of business Thursday, April 4, 2024. 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Early Alzheimer's Disease: Developing Drugs for Treatment.'' This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer's disease (AD) that occur before the onset of overt dementia. This draft guidance revises the previous draft guidance for industry of the same name issued on February 16, 2018.

The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the January 22, 2026, expiration date.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements in the Agency's regulations relating to establishment registration and product listing for manufacturers of human blood and blood products and licensed devices.

The Food and Drug Administration (FDA, Agency, 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.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 22, 2024. The document announced the availability of a final guidance for industry entitled ``Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.'' The document was published with an incorrect docket number. This document corrects that error.

In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

CDC has modified its structure. This notice announces the reorganization of the World Trade Center (WTC) Health Program within the National Institute for Occupational Safety and Health (NIOSH). The WTC Health Program has established three branches.

The Food and Drug Administration (FDA or Agency) is announcing the availability of final guidances for industry entitled ``Q2(R2) Validation of Analytical Procedures'' and ``Q14 Analytical Procedure Development.'' The guidances were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance entitled ``Q2(R2) Validation of Analytical Procedures'' provides a general framework for the principles of analytical procedure validation, including validation principles that cover the analytical use of spectroscopic data. The guidance entitled ``Q14 Analytical Procedure Development'' provides harmonized guidance on scientific approaches for analytical procedure development and describes principles to facilitate more efficient, science-based, and risk-based postapproval change management. The guidances are intended to facilitate regulatory evaluations and potential flexibility in postapproval change management of analytical procedures when scientifically justified. The guidances replace the draft guidances ``Q2(R2) Validation of Analytical Procedures'' and'' Q14 Analytical Procedure Development'' issued on August 29, 2022.

The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Gastrointestinal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Gastrointestinal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the March 3, 2026, expiration date.

This document corrects technical and typographical errors in the final rule entitled, ``Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing'' that was published in the Federal Register on January 9, 2024, and has a stated effective of February 8, 2024.

As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats or formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of Common Formats for SurveillanceHospital Version 1.0 for public review and comment.

The Food and Drug Administration (FDA) 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 Food and Drug Administration (FDA or the Agency) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677-004, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of jet lag disorder. The decision, which also refuses approval of sNDA 205677-004, is available in the docket identified by the number in the heading of this document.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types.''