Department of Health and Human Services November 2023 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 247
Real-Time Oncology Review; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Real-Time Oncology Review (RTOR).'' The purpose of this guidance is to provide recommendations to applicants on the process for submission of selected new drug applications (NDAs) and biologics license applications (BLAs) with oncology indications for review under RTOR. This guidance finalizes the draft guidance of the same title issued on July 22, 2022.
Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022
This final rule describes the agency's actions on remand from the United States (U.S.) District Court for the District of Columbia to craft a remedy in light of the U.S. Supreme Court's decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), relating to the adjustment of Medicare payment rates for drugs acquired under the 340B Program from calendar year (CY) 2018 through September 27th of CY 2022.
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.
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.
Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method
The Food and Drug Administration (FDA) is issuing a final order to revoke the approved method for detecting residues of carbadox, a carcinogenic new animal drug used in swine feed. An approved method is required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as implemented by regulation, to show that no residue of carcinogenic concern from a new animal drug persists in any edible tissue or in any food derived from treated animals. The approved method measures quinoxaline-2-carboxylic acid (QCA) as a marker residue to detect the presence of any residue of carcinogenic concern. QCA is a metabolite of carbadox that FDA has judged does not present a carcinogenic risk. FDA is revoking the approved method for carbadox based on its determination that the method is inadequate to monitor the residue of carcinogenic concern in compliance with FDA's operational definition of no residue because there is no established relationship between the concentration of QCA residues as measured by the approved method and the concentration of the residue of carcinogenic concern.
Phibro Animal Health Corp.; Proposal To Withdraw Approval of New Animal Drug Applications for Carbadox in Medicated Swine Feed; Opportunity for a Hearing
The Food and Drug Administration (FDA or the Agency), Center for Veterinary Medicine (CVM), is proposing to withdraw approval of all new animal drug applications (NADAs) providing for use of carbadox in medicated swine feed, for which Phibro Animal Health Corp., Glenpointe Centre East, Third Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666-6712, is the sponsor, and is announcing an opportunity for the holder of the NADAs to request a hearing on this proposal. This action is based on CVM's determination that there is no approved regulatory method to detect the residue of carcinogenic concern in the edible tissues of the treated swine.
Trusted Exchange Framework and Common Agreement Version 1.1
This notice fulfills an obligation under the Public Health Service Act (PHSA), which requires the National Coordinator for Health Information Technology to publish on the Office of the National Coordinator for Health Information Technology's public internet website, and in the Federal Register, the common agreement developed under the PHSA. This notice is for publishing an updated version of the Common Agreement, version 1.1.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2024
This notice announces a $709.00 calendar year (CY) 2024 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2024 and on or before December 31, 2024.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners-45 CFR Part 60 Regulations and Forms, OMB No. 0915-0126-Revision
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Revision of HHS National Environmental Policy Act Compliance Procedures To Incorporate Federal Flood Risk Management Standard Procedures
HHS is proposing a revision to its floodplain management procedures to include climate science if an action takes place in a floodplain.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2024. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this final rule updates requirements for the ESRD Quality Incentive Program and the ESRD Treatment Choices Model.
Determination That FORADIL (Formoterol Fumarate) Inhalation Powder, 0.012 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, the Agency, or we) has determined that FORADIL (formoterol fumarate) inhalation powder, 0.012 milligrams (mg)/inhalation (inh), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for formoterol fumarate inhalation powder, 0.012 mg/inh, if all other legal and regulatory requirements are met.
Agency Information Collection Activities: Proposed Collection; 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 (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.
Proposed Collection; 60-Day Comment Request; Office of Programs To Enhance Neuroscience (OPEN) Workforce Tracker (National Institute of Neurological Disorders and Stroke)
In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the National Institute of Neurological Disorders and Stroke (NINDS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc. on behalf of Ecoflora SAS (Ecoflora).
Proposed Data Collection Submitted for Public Comment and Recommendations
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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Statement in Support of Application for Waiver of Inadmissibility Under Immigration and Nationality Act. This information collection is related to waivers of inadmissibility on health-related grounds, specifically mental health disorders with associated harmful behavior.
Federal Independent Dispute Resolution Operations
This document sets forth proposed rules related to certain provisions of the No Surprises Act regarding the Federal independent dispute resolution (IDR) process, which was established as part of the Consolidated Appropriations Act, 2021 (CAA). These proposed rules would set forth new requirements relating to the disclosure of information that group health plans and health insurance issuers offering group or individual health insurance coverage must include along with the initial payment or notice of denial of payment for certain items and services subject to the surprise billing protections in the No Surprises Act. These proposed rules would also require plans and issuers to communicate information by using claim adjustment reason codes (CARCs) and remittance advice remark codes (RARCs), as specified in guidance, when providing any paper or electronic remittance advice to an entity that does not have a contractual relationship with the plan or issuer. This document also proposes to amend certain requirements related to the open negotiation period preceding the Federal IDR process, the initiation of the Federal IDR process, the Federal IDR dispute eligibility review, and the payment and collection of administrative fees and certified IDR entity fees. This document also proposes to define bundled payment arrangements, amend requirements related to batched items and services, and amend the rules for extensions of timeframes due to extenuating circumstances. Additionally, this document proposes to require plans and issuers to register in the Federal IDR portal. In accordance with Federal law, a summary of these rules may be found at https://www.regulations.gov/.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Assessment and Evaluation of ACL's American Indian, Alaska Natives, and Native Hawaiian Programs Older Americans Act Title VI (OMB Control Number 0985-0059)
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 Assessment and Evaluation of ACL's American Indian, Alaska Natives, and Native Hawaiian Programs Older Americans Act Title VI (OMB Control Number 0985-0059).
Revocation of Authorization for Use of Brominated Vegetable Oil in Food
The Food and Drug Administration (FDA or we) is proposing to amend our regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. This action is being taken because there is no longer a reasonable certainty of no harm from the continued use of BVO in food. Specifically, the proposed rule would revoke the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. There are no authorizations for other uses of BVO in food.
Enforcement Policy for Clinical Electronic Thermometers; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Enforcement Policy for Clinical Electronic Thermometers.'' This guidance applies to clinical electronic thermometers, which are regulated as class II devices. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers; Request for Comments
The Food and Drug Administration (FDA or the Agency) has identified certain class II clinical electronic thermometers that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with the procedures established by the 21st Century Cures Act. FDA will review any comments submitted within the 60-day comment period and will consider whether any modifications should be made to the exemption for certain clinical electronic thermometers prior to publication of its final determination in the Federal Register.
Privacy Act of 1974; Matching Program
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a computer matching program between CMS and the Office of Personnel Management (OPM), ``Verification of Eligibility of Minimum Essential Coverage Under the Patient Protection and Affordable Care Act through an Office of Personnel Management Health Benefit Plan.''
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Occupational exposures to surgical smoke in veterinary personnel which will characterize occupational exposure to surgical smoke and related respiratory health effects in clinical veterinary settings and provide guidance on engineering controls to improve air quality in veterinary medicine/animal care personnel's work environment by reducing exposure to surgical smoke.
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