Department of Health and Human Services February 2023 – Federal Register Recent Federal Regulation Documents

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

In compliance with of 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.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with general FDA administrative practices and procedures, including requests for formal hearings.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for YUPELRI 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, the Agency, or we) is announcing the following public workshop entitled ``FY 2023 Generic Drug Science and Research Initiatives Workshop.'' The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholdersindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its Fiscal Year (FY) 2024 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Micro-Tracers, Inc., proposing that the food additive regulations be amended to permit the use of ethyl cellulose as a matrix scaffolding in tracers for use in feeds at no more than 0.09 grams per ton of feed (0.1 ppm).

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Understanding Priorities for the Development of Digital Health Technologies To Support Clinical Trials for Drug Development and Review.'' Convened by the Duke-Robert J. Margolis, MD Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis, the purpose of the public workshop is to understand the priorities for the development of Digital Health Technologies (DHTs) to support clinical drug trials, including accessibility, diversity, and clinical outcome measures using DHTs. Additionally, this public workshop meets a Prescription Drug User Fee Amendments (PDUFA VII) commitment to convene the first of a series of public workshops by the end of the second quarter (Q2), fiscal year (FY) 2023.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were 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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. This Generic Clearance is designed to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery.

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, Agency, or we) is classifying the software algorithm device to assist users in digital pathology into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the software algorithm device to assist users in digital pathology's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

The Food and Drug Administration (FDA or the Agency) is denying a request for a hearing submitted by Sami Anwar (Anwar) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Anwar from providing services in any capacity to a person having an approved or pending drug product application. FDA bases this order on a finding that Anwar was convicted of felonies under Federal law for conduct relating to the development or approval of any drug product or otherwise relating to the regulation of a drug product under the FD&C Act. Anwar failed to file with the Agency information and analysis sufficient to create a basis for a hearing concerning this action.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on November 21, 2022. The document announced the withdrawal of approval (as of December 21, 2022) of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of the following ANDAs after receiving withdrawal requests from Sunstar Americas, Inc., 301 East Central Rd., Schaumburg, IL 60195: ANDA 076434, Chlorhexidine Gluconate Solution, 0.12%; Sofgen Pharmaceuticals, LLC, 21500 Biscayne Blvd., Suite 600, Aventura, FL 33180: ANDA 201832, Nimodipine Capsules, 30 milligrams (mg); and Indicus Pharma, LLC, 2530 Meridian Parkway, Durham, NC 27713: ANDA 203419, Donepezil HCl Tablets, 23 mg. Before FDA withdrew the approval of these ANDAs, Sunstar Americas, Inc., Sofgen Pharmaceuticals, LLC, and Indicus Pharma, LLC informed FDA that they did not want the approval of the ANDAs withdrawn. Because Sunstar Americas, Inc. timely requested that approval of ANDA 076434 not be withdrawn, Sofgen Pharmaceuticals, LLC timely requested that the approval of ANDA 201832 not be withdrawn, and Indicus Pharma, LLC timely requested that the approval of ANDA 203419 not be withdrawn, the approvals are still in effect.