Department of Health and Human Services March 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP.''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 This draft guidance is not final nor is it in effect at this time.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 Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of Government information, invites the general public and other Federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Reporting of the Essentials for Childhood (EfC): Preventing Adverse Childhood Experiences through Data to Action Program. This data collection will help to ensure that associated programs are progressing toward achievement of their stated goals and objectives, as well as consistently demonstrating efficient and appropriate use of federal funds.

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 (PRA).

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Validated Follow-up Interview of Clinicians on Outpatient Antibiotic Stewardship Interventions. This collection aims to perform an interview of outpatient clinicians regarding the acceptability and perceived clinician-level barriers associated with our year-long implementation of interventions designed around the Core Elements of Outpatient Antibiotic Stewardship.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Orthopedic Non-Spinal Bone Plates, Screws, and WashersPremarket Notification (510(k)) Submissions.'' This draft guidance document provides recommendations for information to include in 510(k) submissions for non-resorbable bone plate, screw, and washer devices. The scope of this draft guidance includes devices that are indicated for orthopedic bone fixation but does not include devices indicated for spinal, mandibular, maxillofacial, cranial, and orbital fracture fixation. This draft guidance is not final nor is it for implementation at this time.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic 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.

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.

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 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 (PRA).

This notice announces the approval of the application of the Accreditation Commission for Health Care (ACHC) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the ACHC meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant the ACHC deeming authority for a period of 6 years.