Department of Health and Human Services October 2022 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) re-approve the proposed information collection project ``Online Submission Form for Supplemental Evidence and Data for Systematic Reviews for the Evidence-based Practice Center Program.'' This proposed information collection was previously published in the Federal Register on July 19, 2022 and allowed 60 days for public comment. AHRQ did not receive substantive comments during public review period. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #253 entitled ``Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products.'' FDA's Center for Veterinary Medicine (CVM) is issuing this guidance to provide establishments that manufacture animal cells, tissues, and cell- and tissue-based products (ACTPs) with recommendations for meeting requirements for current good manufacturing practice (CGMP). All new animal drugs, including ACTPs, are required to be manufactured in accordance with CGMP to ensure that such drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and have the identity, strength, quality, and purity characteristics, which they purport to or are represented to possess. This guidance also provides FDA's recommendations for those aspects of manufacturing specific to ACTPs in accordance with existing CGMP regulations, as applicable, and with the FD&C Act. In this guidance, we specifically address the methods, facilities, and controls used for manufacturing ACTPs.

The seventh iteration of the Prescription Drug User Amendments (PDUFA VII), included as part of the FDA User Fee Reauthorization Act of 2022, highlights the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The Food and Drug Administration (FDA or Agency) is announcing the continuation of the paired meeting program established under the sixth iteration of PDUFA that affords sponsors, who are selected, the opportunity to meet with Agency staff to discuss the use of complex innovative trial design (CID) approaches in medical product development. Meetings under the program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years 2023 to 2027. For each sponsor whose meeting request is granted, two meetings will be held between the sponsor and CDER or CBER that will provide an opportunity for medical product developers to discuss their CID proposals. To promote innovation in this area, trial designs developed through the paired meeting program may be presented by FDA (e.g., in a guidance or public workshop) as case studies, including trial designs for drugs that have not yet been approved by FDA.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect qualitative data to examine innovative and promising consumer education strategies that Child Care and Development Fund (CCDF) Lead Agencies are using to help families search for and select child care and early education (CCEE). This information collection aims to present an internally valid description of the experiences of up to six, purposively selected case study sites, not to promote statistical generalization to different sites or service populations.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF-Tribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program Form 2: Grantee Performance Measures (Office of Management and Budget (OMB) #0970-0500; Expiration date Feb 28, 2023). There are no changes requested to the form.

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) is announcing an amendment to the notice of meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the Federal Register of September 8, 2022. The amendment is being made to reflect changes in the DATES, ADDRESSES, and SUPPLEMENTARY INFORMATION portions of the document. The meeting was rescheduled to allow time for FDA to review new information submitted to the application. There are no other changes.

Through this Request for Information (RFI), the Sexual & Gender Minority Research Office (SGMRO) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), invites feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on research opportunities related to the upcoming NIH Scientific Workshop on Gender-Affirming Care for Transgender and Gender-Diverse Populations. Current evidence-based clinical practices are available for health professionals to assist transgender and gender-diverse populations but additional research is needed to advance this area of care. The overarching purpose of this workshop is to identify and prioritize key infrastructure and research needed to further our understanding of gender affirming care for transgender and gender diverse populations across the life course. Various populations (e.g., people with HIV, people with other co-morbidities and complications, racial and ethnic minorities, etc.) and settings (academic medical centers, Federally Qualified Health Centers, community hospitals, HIV care settings, etc.) will be considered.

The Office of the Assistant Secretary for Health published a notice of an upcoming meeting of the Tick-Borne Disease Working Group (TBDWG) in the Federal Register on September 16, 2022. This addendum provides notice of an additional day added to the October 25, 2022 meeting. The 24th meeting of the TDBWG will now take place from October 24-25, 2022. The September 16th Federal Register notice can be accessed at https://www.federalregister.gov/documents/2022/09/16/2022-200 88/ meeting-of-the-tick-borne-disease-working-group.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Tissue Agnostic Drug Development in Oncology.'' For the purpose of this guidance, the term ``tissue agnostic oncology drug'' refers to a drug that targets a specific molecular alteration(s) (a kind of biomarker) across multiple cancer types as defined, for example by organ, tissue, or tumor type. This draft guidance describes the development of tissue agnostic drugs, scientific considerations in determining when tissue agnostic oncology drug development may be appropriate, and, if appropriate, issues to be addressed during such development. Tissue agnostic drug development may expedite or enable the development of new therapies for patients with rare cancer types.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Gregory Settino from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Settino was convicted of a felony under Federal law for conduct that relates to the regulation of any drug product under the FD&C Act. Mr. Settino was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of August 15, 2022 (30 days after receipt of the notice), Mr. Settino had not responded. Mr. Settino's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.'' This guidance is intended for sponsors of cancer immunotherapeutic drugs that modulate the endogenous immune system and may break immunologic tolerance to normal organs and tissues; it provides recommendations regarding the data that should be collected and evaluated to assess whether adverse events are immune-mediated adverse reactions (imARs) and the data on imARs that should be included in a new drug application (NDA) or biologics license application (BLA) for a cancer immunotherapeutic drug.

In compliance with the requirement for opportunity 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 Advisory Commission on Childhood Vaccines (ACCV) provides advice and recommendations to the Secretary of HHS (Secretary) on policy, program development, and other issues related to the implementation of the National Vaccine Injury Compensation Program (VICP) and concerning other matters as described under the Public Health Service Act. To ensure compliance with the statutory requirement that the ACCV meet not less than four times per year, this notice announces that the ACCV meeting originally scheduled for March 3, 2022, has been rescheduled for December 2, 2022.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Mine Safety and Health Research Advisory Committee (MSHRAC). This is a virtual meeting only. It is open to the public, limited only by the number of web conference lines (500 web conference lines are available). If you wish to attend virtually, please register according to the instructions in the addresses section below. Time will be available for public comment.