Department of Health and Human Services June 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Mouse Embryo Assay for Assisted Reproduction Technology Devices.'' This draft guidance document provides recommendations on conducting the Mouse Embryo Assay (MEA) to support premarket submissions and lot release of assisted reproduction technology devices. This draft guidance is not final nor is it in effect at this time.

In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Clinical Center, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALUNBRIG 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.

The Food and Drug Administration (FDA, Agency, or we) has determined that NIZORAL (ketoconazole) topical cream, 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

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

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BAXDELA IV INJECTION under new drug application (NDA) 208611 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled ``Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of February 27, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA, the Agency, or we) 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.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled ``Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making.'' The purpose of this public workshop is to discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making; share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach; obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions. This public workshop is also being conducted to satisfy one of FDA's performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD).

This document announces the extension of the timeline for publication of the ``Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care'' final rule. We are issuing this document in accordance with section 1871(a)(3)(B) of the Social Security Act (the Act), which requires notice to be provided in the Federal Register if there are exceptional circumstances that cause us to publish a final rule more than 3 years after the publication date of the proposed rule. In this case, the complexity of the rule, its substantive nature, and the scope of comments received all warrant the extension of the timeline for publication.

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 Prevalence Survey of Healthcare- Associated Infections and Antimicrobial Use in U.S. Acute Care Hospitals. This project examines the numbers and types of Healthcare- Associated Infections and causative pathogens, types of antimicrobial drugs (such as antibiotics) used, and the quality of antimicrobial prescribing in U.S. acute care hospitals.

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.

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.