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

This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is a virtual meeting and is open to the public. Written comments will be accepted and registration is required to present oral comments.

HRSA published a notice in the Federal Register on December 20, 2022, concerning 2023 calendar year meetings of the Advisory Commission on Childhood Vaccines (ACCV). The document contained incorrect dates for future meetings. The remaining 2023 ACCV meetings will be held on September 7, 2023, 10:00 a.m. Eastern time (ET)-4:00 p.m. ET and September 8, 2023, 10:00 a.m. ET-4:00 p.m. ET.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP.'' This guidance is intended to assist institutional review boards (IRBs), institutions, investigators, and sponsors in understanding the processes used for review of research involving children as subjects that is not otherwise approvable by an IRB and has been referred to FDA, the Office for Human Research Protections (OHRP), or both, for review. When final, this guidance will replace the final guidance issued by FDA in December 2006 entitled, ``Guidance for Clinical Investigators, Institutional Review Boards and Sponsors: Process for Handing Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations'' and the guidance issued by the OHRP entitled ``Children as Research Subjects and the HHS `407' Process,'' issued on May 26, 2005. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #281 entitled ``Infectious Otitis Externa Drugs for Topical Use in Dogs.'' This draft guidance provides recommendations to help sponsors complete the effectiveness, target animal safety, and labeling technical sections of a new animal drug application (NADA) for infectious otitis externa drugs for topical use in dogs.

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

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for M6-C ARTIFICIAL CERVICAL DISC 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 a patent which claims that medical device.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) is issuing a final order to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures, an unclassified, preamendments device following the classification of the device into class III.

The Secretary of the U.S. Department of Health and Human Services (HHS) has statutory authority to exempt the Advanced Research Projects Agency for Health (ARPA-H) from certain policies and requirements of the National Institutes of Health (NIH) as necessary and appropriate to ensure ARPA-H can most effectively achieve its statutorily specified goals. Pursuant to such authority, and for the reasons stated herein, the Secretary is giving notice that he intends to exempt ARPA-H from all NIH policies and requirements subject to the limitations and condition stated herein.

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, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Identification of Medicinal ProductsImplementation and Use.'' This guidance explains FDA's position and progress on aligning the Agency's standards to Identification of Medicinal Products (IDMP) standards, which the Agency supports, to identify and describe marketed medicinal products with the exception of investigational medicinal products, with the goal of harmonizing the standards for the international exchange of medicinal product data. The guidance is intended to assist sponsors, applicants, and registrants who are involved in the regulatory submission of medicinal product data.

In accordance with the Federal Advisory Committee Act (FACA), the Department of Health and Human Services is hereby giving notice that the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL or Advisory Committee) has been rechartered. The effective date of the renewed charter is March 24, 2023.

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Migrant Health (NACMH) scheduled a public meeting. Information about NACMH and the agenda for this meeting can be found on NACMH's website at https:// www.hrsa.gov/advisory-committees/migrant-health.

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) announces a forthcoming public advisory committee meeting of the Pulmonary-Allergy Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``General Considerations for Animal Studies Intended to Evaluate Medical Devices.'' FDA developed this guidance document to assist medical device sponsors, testing facilities, and other persons involved in designing, conducting, and reporting the results of animal studies intended to assess the safety of medical devices to support premarket submissions. These animal studies typically provide initial evidence of device safety, which may include device performance and handling, and the biological effects when used in a living system.

The Office of the Assistant Secretary for Health published a document in the Federal Register of September 14, 2022, inviting public and private sector organizations to apply to become a Women's Health Champion. The document includes contact information for a staff member who is no longer working in the Office on Women's Health.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Advisory Committee on Breast Cancer in Young Women (ACBCYW). This meeting is open to the public, limited only by audio and web conference lines (150 web conference participant spaces available). Online registration is required.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Soft (Hydrophilic) Daily Wear Contact LensesPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidance identified in this notice was developed in accordance with the final guidance entitled ``Safety and Performance Based Pathway.''

The Centers for Medicare and Medicaid Services, Center for Medicare, Office of Minority Health has modified its organizational structure.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry.'' The draft guidance, when finalized, will provide FDA's current thinking on the use of Dietary Guidance Statements on packaged food labels and more broadly in the labeling of foods, including any written, printed, or graphic material accompanying a food, such as labeling on websites. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).'' FDA recognizes that it will take time for device manufacturers, device distributors, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the COVID-19 pandemic to ``normal operations.'' To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA's general recommendations for this transition process with respect to devices issued EUAs related to COVID-19, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices.