Department of Health and Human Services August 29, 2022 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Measure Dx: A Resource to Identify, Analyze, and Learn from Diagnostic Safety Events.'' This proposed information collection was previously published in the Federal Register on June 15, 2022 and allowed 60 days for public comment. AHRQ did not receive substantive comments from members of the public during this period. The purpose of this notice is to allow an additional 30 days for public comment.
Meeting for Software Developers on the Common Formats for Patient Safety Data Collection
AHRQ coordinates the development of sets of standardized definitions and formats (Common Formats) that make it possible to collect, aggregate, and analyze uniformly structured information about health care quality and patient safety for local, regional, and national learning. The Common Formats include technical specifications to facilitate the collection of electronically comparable data by Patient Safety Organizations (PSOs) and other entities. Additional information about the Common Formats can be obtained through AHRQ's PSO website at https://pso.ahrq.gov/common-formats and the PSO Privacy Protection Center's website at https://www.psoppc.org/psoppc_web/ publicpages/commonFormatsOverview. The purpose of this notice is to announce a meeting to discuss implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.
M12 Drug Interaction Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``M12 Drug Interaction Studies.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides general recommendations on how to evaluate the pharmacokinetic drug interaction potential mediated via enzyme and transporter for investigational drugs. The draft guidance harmonizes the regional requirements on in vitro and clinical evaluation of drug-drug interactions for a more consistent approach in design, conduct, and interpretation of enzyme and transporter-mediated interaction during the development of an investigational drug. The draft guidance is intended to decrease the risk of adverse events, sometimes leading to hospital admissions or reduced treatment efficacy.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ZYNTEGLO (betibeglogene autotemcel), manufactured by bluebird bio, Inc., meets the criteria for a priority review voucher.
E11A Pediatric Extrapolation; International Council for Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E11A Pediatric Extrapolation.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance provides a comprehensive and systematic approach to the use of pediatric extrapolation during drug development. The draft guidance also discusses study designs and statistical methodologies, including modeling and simulation, that can be utilized to develop and implement a pediatric extrapolation approach. The draft guidance is intended to provide recommendations for the use of pediatric extrapolation during drug development, which, when used appropriately, can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children.
Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development; International Council for Harmonisation; Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances for industry entitled ``Q2(R2) Validation of Analytical Procedures'' and ``Q14 Analytical Procedure Development.'' These draft guidances were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. These draft guidances harmonize scientific approaches for analytical procedure development and include validation of a wider range of analytical techniques. The draft guidances are intended to facilitate regulatory evaluations and facilitate potential flexibility in postapproval change management of analytical procedures. The draft Q2(R2) guidance revises the ICH guidance for industry ``Q2(R1) Validation of Analytical Procedures: Text and Methodology'' published in November 2005.
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential-Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic PotentialQuestions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The guidance contains revised questions and answers (Q&As) for the ICH guidance for industry ``E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs'' and new Q&As for the ICH guidance for industry ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals'' that provide recommendations on considerations for an integrated risk assessment combining nonclinical and clinical datain particular, at later stages of drug development when clinical data are available. The guidance is intended to provide a harmonized approach to integrate nonclinical and clinical information for proarrhythmia risk assessment to streamline drug development and provide clarity on regulatory decision making. This guidance finalizes the draft guidance of the same title issued in September 2020.
Authorization of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use during the COVID-19 pandemic. FDA has issued one Authorization for a biological product as requested by Novavax, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher
The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act, authorizes FDA to award priority review vouchers to sponsors of a material threat medical countermeasure application that meets certain criteria upon approval of such application. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the application for MOUNJARO (tirzepatide) injection, approved May 13, 2022, meets the redemption criteria.
Radiation Oncology (RO) Model
We are finalizing our proposal to delay the current start date of the RO Model to a date to be determined through future rulemaking, and to modify the definition of the model performance period to provide that the start and end dates of the model performance period for the RO Model will be established in future rulemaking.
Food Additives Permitted in Feed and Drinking Water of Animals; Fumonisin Esterase
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of fumonisin esterase to degrade fumonisins present in poultry feed. This action is in response to a food additive petition filed by Biomin Holding GmbH.
Advisory Committee on Immunization Practices (ACIP)
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment.
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Extension of Comment Period
The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announce the extension of the comment period for the proposed rule entitled ``Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Submissions
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.
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