Department of Health and Human Services 2023 – Federal Register Recent Federal Regulation Documents
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Action to Delay Effective Date Consistent With Congressionally Enacted Moratorium
This action stays certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule (``Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees'') published in the Federal Register on November 30, 2020 (the 2020 Final Rule). In response to a moratorium enacted by Congress on implementation of the 2020 Final Rule, most recently in section 11301 of the Inflation Reduction Act of 2022, which extended previous moratoria on implementation, administration, or enforcement of the 2020 Final Rule until January 1, 2032, the new effective date for the amendments set forth in the 2020 Final Rule is January 1, 2032.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Health Service Corps Scholar/Students to Service Travel Worksheet, OMB No. 0915-0278-Revision
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.
Announcement of the Advisory Panel on Outreach and Education (APOE) Virtual Meeting
This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories
This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. This final rule implements a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. We are finalizing the incorporation of limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. We are also finalizing the distribution of the administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees. In addition, we are finalizing the clarification of the methodology used to determine program compliance fees. This final rule ensures the continuing quality and safety of laboratory testing for the public. This final rule also amends histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes. In addition, this final rule amends the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite State monitoring) to allow for the imposition of such sanctions on CoW laboratories.
Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance entitled ``Potency Assurance for Cellular and Gene Therapy Products.'' FDA is issuing this draft guidance to provide recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. FDA is recommending a comprehensive approach to potency assurance of CGT products that is grounded in quality risk management. For investigational products, we describe how to progressively implement a strategy for potency assurance during product development and provide additional considerations to help assure the potency of products that are undergoing rapid clinical development. For licensed products, we describe requirements for potency assurance, including testing required for lot release.
Quality Considerations for Topical Ophthalmic Drug Products; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Quality Considerations for Topical Ophthalmic Drug Products.'' This revised draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., gels, ointments, creams, and liquid formulations such as solutions, suspensions, and emulsions) intended for topical delivery in and around the eye. Specifically, this revised draft guidance discusses microbiological considerations; approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug release/ dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms; recommendations for design and delivery and dispensing features of container closure systems; and recommendations for stability studies. The revised draft guidance applies to marketed products including ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as to over-the-counter (OTC) monograph drugs, drugs compounded by outsourcing facilities, and the drug or biological product constituent part of a combination product. This guidance revises the draft guidance for industry of the same name issued in October 2023.
Electronic Submissions; Update to the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports for Vaccines; Technical Specification
The Food and Drug Administration (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing the availability of version 2.3 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRS) for Vaccines (Specifications). The version update is not applicable to CBER- regulated drug products marketed for human use with approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs); CBER-regulated therapeutic biological products marketed for human use with approved Biologic License Applications (BLAs); Whole Blood or blood components; and human cells, tissues, and cellular and tissue- based products (HCT/Ps) regulated solely under the Public Health Service Act.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Health Insurance Assistance Program Annual Sub-Recipients Report OMB Control Number 0985-0070
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 extension without change for the information collection requirements related to State Health Insurance Assistance Program Annual Sub-Recipients Report OMB Control Number 0985-0070.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Alzheimer's and Dementia Program Data Reporting Tool (ADP-DRT) OMB Control Number 0985-0022
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 Alzheimer's and Dementia Program Data Reporting Tool (ADP-DRT) OMB Control Number 0985-0022.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Title VI Program Performance Report (OMB Control Number 0985-0007)
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 Title VI Program Performance Report (OMB Control Number 0985-0007).
Agency Information Collection Activities: Proposed Collection; Public Comment Request; of the Performance Data for State Grants for Assistive Technology Program Annual Progress Report (OMB Control Number 0985-0042)
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 information collection (IC) extension solicits comments on the information collection requirements relating to the Performance Data for State Grants for Assistive Technology Program Annual Progress Report (OMB Control Number 0985-0042).
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-July Through September 2023
This quarterly notice lists the OMHA Case Processing Manual (OCPM) instructions that were published from July through September 2023. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Health Insurance Assistance Program (SHIP) Client Contact Forms OMB Control Number 0985-0040
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 State Health Insurance Assistance Program (SHIP) Client Contact Forms OMB Control Number 0985-0040.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Advanced Nursing Education Program Specific Form OMB No. 0915-0375-Revision
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.
Proposed Information Collection Activity; Immigration Legal Services for Afghan Arrivals-Eligible Afghan Arrivals Intake Form and Intake Interview (New Collection)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data from Eligible Afghan Arrivals (EAAs) in need of direct legal services through Immigration Legal Services for Afghan Arrivals (ILSAA) to determine eligibility.
Reformulating Drug Products That Contain Carbomers Manufactured With Benzene; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Reformulating Drug Products That Contain Carbomers Manufactured With Benzene.'' The purpose of this guidance is to provide recommendations to applicants and manufacturers on what tests should be performed and what documentation should be submitted or available to support the reformulation of drug products that use carbomers manufactured with benzene. Certain United States Pharmacopeia (USP) carbomer monographs currently allow for unacceptable levels of benzene, which raises safety concerns. FDA has requested that the USP omit (or remove) these monographs, and applicants and manufacturers may need to reformulate their drug products to avoid use of these carbomers. This guidance provides recommendations for tests and documentation related to reformulation based on various routes of administration and dosage forms of affected drug products, and provides recommendations for application holders on the appropriate submission types to notify the Agency of reformulation changes. The intended effect of this guidance is to, as appropriate, provide a less burdensome risk-based approach to reformulation submissions relative to existing guidances on scale-up and post-approval changes (SUPAC), and address the immediate public health need to expedite the discontinuation of the use of carbomers manufactured with high levels of benzene in drug products.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Advisory Child Health and Human Development Council Stillbirth Working Group Meeting
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Stillbirth Working Group of Council is charged with identifying current knowledge on stillbirth and prevention, areas of improvement for data collection, current resources for families impacted by stillbirth, and next steps to gather data and lower the rate of stillbirth in the United States.
Medicare Program: Appeal Rights for Certain Changes in Patient Status
This proposed rule would implement an order from the Federal district court for the District of Connecticut in Alexander v. Azar that requires HHS to establish appeals processes for certain Medicare beneficiaries who are initially admitted as hospital inpatients but are subsequently reclassified as outpatients receiving observation services during their hospital stay and meet other eligibility criteria.
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers.'' We are issuing this small entity compliance guide (SECG) in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the ``Direct-to- Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule'' (CCN Final Rule). The CCN Final Rule modifies FDA regulations to reflect the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that human prescription drug advertisements presented directly to consumers (DTC) in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads) present the major statement relating to side effects and contraindications (major statement) in a clear, conspicuous, and neutral manner and establishes standards to help ensure this requirement is met. The term ``drugs'' in this guidance refers to prescription human drug and biological products.
Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use); Chromium Propionate; Correction
The Food and Drug Administration is correcting a notice entitled ``Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)'' that appeared in the Federal Register of July 27, 2023. The document announced that we filed a petition, submitted by Kemin Industries, Inc., proposing that the food additive regulations be amended to provide for the safe use of chromium propionate to be used as a source of chromium in turkey feed. The document was published with an incorrect docket number. This document corrects that error.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZOKINVY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZOKINVY 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 patents which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; PONVORY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PONVORY 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 human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; CYTALUX
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CYTALUX 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 human drug product.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group (IRG) Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.
Government Owned Inventions
The invention listed below is directed to a T cell receptor (TCR) that specifically targets the Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1). This TCR may be used to develop novel immunotherapies against several common and aggressive epithelial cancers. It may also be possible to use portions of the KK-LC-1 TCR in chimeric proteins for cancer therapy and/or for antigen detection assays. This technology was discovered and is being developed by the National Cancer Institute (NCI). The NCI is currently seeking a licensee and/or collaborator to further develop this technology.
Determination of Regulatory Review Period for Purposes of Patent Extension; SCEMBLIX
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SCEMBLIX 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 human drug product.
National Advisory Child Health and Human Development Council Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Implementation Working Group Meeting
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) PRGLAC Implementation Working Group of Council is charged with monitoring and reporting on implementation of the recommendations from the PRGLAC. This includes monitoring and reporting on implementation, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical trials.
Request for Public Comments on Co-Occurring Conditions in Autism
On behalf of the Interagency Autism Coordinating Committee (IACC), the National Institute of Mental Health (NIMH) Office of National Autism Coordination (ONAC) is seeking public comments to assist the IACC in identifying priorities related to physical and mental health conditions, and other related conditions that commonly co-occur with autism. The IACC is requesting public comments on the impact of these co-occurring conditions, as well as research, services, and policy needs that may be helpful to consider in addressing issues related to these conditions.
Agency Information Collection Request. 30-Day Public Comment Request
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.
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