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

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.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC). This is a hybrid meeting, accessible both in person and virtually (webcast live via the World Wide Web). It is open to the public and limited only by the space available. Time will be available for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year (FY) 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. This notice publishes the OMUFA fee rates for FY 2023.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' 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 public health emergency (PHE) 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 a phased transition process with respect to devices that fall within certain enforcement policies issued during the COVID-19 PHE declared by the Secretary of Health and Human Services (the Secretary) under the Public Health Service Act (PHS Act), including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. This guidance applies to devices that fall within enforcement policies in guidances included in List 1 of this guidance. The phased transition process outlined in this guidance will begin on the ``implementation date.'' The implementation date is the day the PHE expires or 45 days after the finalization of this guidance, whichever comes later. Because the COVID-19 section 319 PHE declaration is anticipated to expire at least 45 days after the finalization of this guidance, or May 11, 2023, the implementation date is that date. The guidances in List 1 of this guidance will no longer be in effect after the 180-day transition period ends.

In accordance with the requirements of the Privacy Act of 1974, as amended, HHS is modifying a system of records maintained by HRSA's Bureau of Health Workforce, System Number 09-15-0054, National Practitioner Data Bank (NPDB).

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, Advancing Violence Epidemiology in Real-Time (AVERT). This data collection will help improve state and local jurisdictions' ability to identify, respond to, and prevent violence.

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.

Notice is hereby given for the meeting on April 27, 2023, of the Substance Abuse and Mental Health Services Administration National Advisory Council (SAMHSA NAC). The meeting is open to the public and can also be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https:// www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of the meeting minutes of August 10, 2022; updates and recap of the joint meetings of the councils (JNAC) and Lessons Learned; presentations on initiatives by the National Mental Health and Policy Laboratory; update on the Strategic Plan and Public Comment Response; and Overview of the Evidence-Based Practices Resource Center with group discussion; a presentation and discussion regarding the integration of equity; updates on the Interagency Task Force on Trauma Informed Care; updates on the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC); updates on the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC); Council discussion and public comments.

This document extends the comment period for the proposed rule that appeared in the Federal Register on December 21, 2022, titled ``Administrative Simplification: Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard. The comment period for the proposed rule, which would end on March 21, 2023, is extended until April 21, 2023.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CINTEC PLUS CYTOLOGY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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.

This symposium is sponsored by the NIH Office of Research on Women's Health (ORWH), the title of this year's symposium is ``Menopause and Optimizing Midlife Health of Women.'' The symposium will discuss menopausal transition, accumulation of morbidity after menopause, menopause in special populations, social determinants of health, menopausal hormonal therapy, and interventions to promote healthy aging.

The National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD or the Committee) is required by the PHS Act as amended by the Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) and governed by the provisions of the Federal Advisory Committee Act (FACA). The NACIDD shall evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS and ASPR to support and enhance all-hazards public health and medical preparedness, response, and recovery aimed at meeting the needs of people with disabilities. The Secretary of HHS has delegated authority to operate the NACIDD to ASPR.

OPRE and the Family and Youth Services Bureau (FYSB) in ACF request an extension to a currently approved information collection of performance measures data for the PREP Program (OMB No. 0970-0497; expiration date: 06/30/2023). The purpose of the request is to (1) continue the ongoing data collection and submission of the performance measures by PREP grantees and (2) eliminate the requirement for grantees to aggregate participant survey data to the program level for submission.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

HRSA is updating income levels used to identify a ``low-income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in the Public Health Service Act. HHS periodically publishes in the Federal Register, low-income levels to be used by institutions receiving grants or cooperative agreement awards to determine eligibility for programs providing training for disadvantaged individuals, individuals from disadvantaged backgrounds, or individuals from low-income families.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the award of approximately $8,000,000, for Year 1 funding to the Gambella Regional Health Bureau (GRHB). The award will improve the capacity of HIV program management and quality of health services to attain epidemic control in the Gambella Regional State of Ethiopia.