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

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Tissue Agnostic Drug Development in Oncology.''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 This draft guidance describes the development of tissue agnostic drugs, scientific considerations in determining when tissue agnostic oncology drug development may be appropriate,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.

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Molecular Targeting Technologies, Inc. (MTTI); a Delaware corporation, with its principle place of business in West Chester, Pennsylvania, to practice the inventions embodied in the issued patents and patent applications listed in the Supplementary Information section of this notice.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.'' This final guidance is intended to assist original applicants and holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) on implementing a chemistry, manufacturing, and controls (CMC) postapproval change(s) through the use of a comparability protocol (CP). In many cases, submission and approval of a CP will facilitate the subsequent implementation and reporting of CMC changes, which could result in moving a drug or biological product into distribution or facilitating a proactive approach to reinforcing the supply of a product sooner than if a CP were not used. This final guidance recommends a framework to promote continuous improvement in the manufacturing of quality drug and biological products. This document finalizes a revised draft guidance that published on April 20, 2016, entitled ``Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.'' A related draft guidance entitled ``Comparability ProtocolsProtein Drug Products and Biological ProductsChemistry, Manufacturing, and Controls Information'' that published in September 2003, was withdrawn on May 6, 2015.

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 the information collection provisions of FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements.

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.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR). This is a hybrid meeting, accessible both in person and virtually. It is open to the public and limited only by the space available and the number of internet conference accesses available. Time will be available for public comment.