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

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 National Advisory Council for Healthcare Research and Quality (the Council) advises the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and works within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven new members will be appointed to replace seven current members whose terms will expire in November 2023.

The National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Oncala Bio Inc. (``Oncala Bio''), headquartered in Bend, OR.

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 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.

The Food and Drug Administration (FDA, Agency, or we) is amending its regulations to update the address, email address, and office name for the Office of Policy, Legislation, and International Affairs, Office of Global Policy and Strategy. This technical amendment is to ensure accuracy and clarity in the Agency's regulations and is nonsubstantive.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.'' The purpose of this guidance is to provide recommendations to sponsors of anti-cancer drugs or biological products on considerations for designing trials intended to support accelerated approval. The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious and life-threatening nature of cancer. Although single-arm trials have been commonly used to support accelerated approval, a randomized controlled trial is the preferred approach as it provides a more robust efficacy and safety assessment and allows for direct comparisons to an available therapy. This guidance describes considerations for designing, conducting, and analyzing data for trials intended to support accelerated approvals of oncology therapeutics.

The Office on Trafficking of Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting renewal with revisions to the instruments previously approved for the National Human Trafficking Training and Technical Assistance Center (NHTTAC) Evaluation Package (Office of Management and Budget (OMB) #0970-0519, expiration 03/31/2023). Items were expanded to include measures related to specific skills, competencies, and knowledge and outcomes at the organizational and community levels, and the annual burden has increased for several forms.

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 Public Health Law Fellowship Program Information Collection. The goal of this information collection request (ICR) is to obtain a new ICR using nine data collection instruments including two applications, five surveys, one interview guide, and one focus group guide assessing the quality and value of the Public Health Law Program Fellowship (PHL Fellowship).

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.

Notice is hereby given of the combined (joint) meeting on April 26, 2023, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) four National Advisory Councils: the SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC; and the two SAMHSA Advisory Committees: Advisory Committee for Women's Services (ACWS) and the Tribal Technical Advisory Committee (TTAC).

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 we) is amending its regulations that pertain to food labeling, infant formula requirements, food additives, direct food substances affirmed as generally recognized as safe (GRAS), and new dietary ingredient (NDI) notifications. These amendments correct typographical errors, correct errors in sample labels, restore inadvertent omissions, and update office and organization names, addresses, and other references. This action is ministerial or editorial in nature.

The Agency for Healthcare Research and Quality (AHRQ) invites public comment in response to this Request for Information (RFI) about a potential Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) survey to assess patients' prenatal care and childbirth care experiences in ambulatory and inpatient care settings. Currently, no CAHPS instrument is available that is specifically designed to measure prenatal and childbirth care from the patient's perspective in these settings. Accordingly, this RFI seeks comments regarding methodologically sound approaches to assessing prenatal and childbirth care experiences in healthcare settings about topics such as communication with providers, respect, access to services, and patients' perceptions of bias in receiving care. This RFI also seeks comments about any (1) existing patient experience surveys or survey items that might be incorporated into public domain CAHPS ambulatory and inpatient prenatal and childbirth experience surveys; and, (2) special considerations or concerns associated with the collection of such information. This RFI will help inform the development of scientifically sound surveys to potentially measure the experience of patients receiving prenatal and childbirth care.

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.