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

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its human prescription drug product labeling regulations for Medication Guides (FDA-approved written prescription drug product information distributed to patients). This action, if finalized, will require applicants to create a new type of Medication Guide, referred to as Patient Medication Information (PMI), for prescription drug products, including biological products, used, dispensed, or administered on an outpatient basis and for blood and blood components transfused in an outpatient setting. PMI would be a one-page document with standardized format and content that would be submitted to FDA for approval. This proposed rule is intended to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

This notice is to inform the public the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a supplement (in scope of the parent award) for the grant recipient funded in FY 2020 under the Homeless and Housing Resource Center (HHRC) Notice of Funding Opportunity (NOFO) SM-20-009. The recipient may receive up to $498,500 in supplemental funds. The recipient has a project end date of August 30, 2024. The supplemental funding will be used to address substance use and/or mental disorders associated with service access and delivery and systems needs related to unsheltered and rural homelessness.

The Administration for Children and Families' (ACF) Office of Refugee Resettlement (ORR) plans to submit a generic information collection (GenIC) request under the following umbrella generic: Generic Clearance for Financial Reports used for ACF Mandatory Grant Programs (0970-0510). This request is to include instructions for ORR Refugee Cash and Medical Assistance (CMA) grant recipients to provide supplemental financial information when submitting the already required ORR-2 Financial Report, which is approved under Office of Management and Budget (OMB) number 0970-0407.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on the proposed collection. The request consists of several forms that allow the ORR Unaccompanied Children (UC) Program to enhance monitoring efforts at care provider facilities that are not licensed by the State, as well as continue standard monitoring activities that ensure its care provider facilities are in compliance with Federal and State laws and regulations, licensing and accreditation standards, ORR policies and procedures, and child welfare standards. This notice is specific to forms that were recently approved through emergency approval for 180 days and additional proposed forms.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the collection of information under the Child and Family Services Plan (CFSP), the Annual Progress and Services Report (APSR), and the Annual Budget Expenses Request and Estimated Expenditures (Child and Family Services (CFS)-101): Office of Management and Budget (OMB) #0970-0426, expiration September 30, 2023. There are minor changes to the CFS-101 form and no changes to the burden hours.

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.

In compliance with the requirement 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.

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.

This proposed rule would seek to implement policies in the Medicaid Drug Rebate Program (MDRP) related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), which are needed to address drug misclassification, as well as drug pricing and product data misreporting by manufacturers. Additionally, we are proposing several other program integrity and program administration provisions or modifications in this proposed rule including revising and proposing key definitions used in the MDRP. This proposed rule also designates a time limitation on manufacturers initiating audits with States; clarifies and establishes requirements for State fee-for-service (FFS) pharmacy reimbursement; codifies conditions relating to States claiming FFP for physician-administered drugs (PADs); clarifies the requirement of accumulating price concessions when determining best price; designates drug price verification and transparency through data collection; and proposes two new contracting requirements between States and their Medicaid managed care plans. In addition, this rule includes a proposal unrelated to MDRP that would make revisions to the third-party liability regulation due to Bipartisan Budget Act (BBA) of 2018. Finally, we are proposing to rescind revisions made by the December 31, 2020 final rule ``Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements'' to the Determination of Best Price and Determination of Average Manufacturer Price (AMP) sections.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.'' The guidance represents the current thinking of FDA on adjusting for covariates in randomized clinical trials for drugs and biological products. The guidance discusses general recommendations for performing covariate adjustment, recommendations for performing covariate adjustment using linear models, and recommendations for performing covariate adjusting using nonlinear models. The guidance is intended to facilitate covariate adjustment in the analysis of randomized clinical trials of drugs and biological products and to clarify recommendations for its use. The guidance finalizes the revised draft guidance entitled ``Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products'' issued on May 21, 2021.

The Children's Bureau (CB), the Administration for Children and Families (ACF) is requesting a three-year extension of the data information collection for the Adoption and Foster Care Analysis and Reporting System (AFCARS) that was implemented as part of the AFCARS final rule published in May 2020 (85 FR 28410). There are no proposed changes to the data information collection published as the regulation in May 2020. The estimated time per response related to record keeping has been revised since the previous published notice (88 FR 16449) due to feedback from the State and Tribal reporting agencies.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Measures for Primary Healthcare Spending, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), plans to request review and approval by the Office of Management and Budget (OMB) of the information collection listed below.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP-STAC). This virtual meeting is open to the public. Time will be available for public comment.

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 a generic collection of information through which we intend to seek insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services.

The Food and Drug Administration (FDA or Agency) has determined that Chirocaine (levobupivacaine) injection, 2.5 milligrams (mg) (base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for levobupivacaine injection, 2.5 milligrams (mg) (base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers.'' This guidance represents FDA's current thinking on the use of whole slide images during good laboratory practice (GLP)-compliant toxicology studies. Documentation practices during generation, use, and retention of whole slide images have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer document is intended to clarify FDA's recommendations concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted in compliance with the GLP regulations. This guidance finalizes the draft guidance of the same title issued on April 8, 2022.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information.'' This draft guidance is intended to assist sponsors in determining whether it may be appropriate to rely on generally accepted scientific knowledge (GASK) to fulfill certain legal and regulatory requirements applicable to the new drug application (NDA) or biologics licensing application (BLA) in question. When final, this guidance will represent the Agency's current thinking on this topic.