Department of Health and Human Services March 2020 – Federal Register Recent Federal Regulation Documents

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The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised final guidance entitled ``Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry.'' The final guidance document provides blood and plasma establishments with revised recommendations related to biological product deviation (BPD) reporting. The guidance is intended to assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report. The revised guidance explains that we do not consider post donation information (PDI) events to require BPD reports. The revised guidance also contains other technical updates and editorial revisions to improve clarity and provide a more streamlined document. For the purposes of this guidance, ``blood and plasma establishment'' includes licensed manufacturers of blood and blood components, including Source Plasma, unlicensed registered blood establishments, and transfusion services. The guidance announced in this notice supersedes the document entitled ``Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments,'' dated October 2006.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``510(k) Third Party Review Program.'' This guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third Party (3P510k) Review Program authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FDA Reauthorization Act of 2017 (FDARA), FDA was directed to issue guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. The 3P510k Review Program is intended to allow review of devices by 3P510k Review Organizations in order to provide manufacturers of these devices an alternative review process that allows FDA to best utilize our resources on higher risk devices.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Evaluation of Learning Health Systems K12 Training Program.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled ``Q3D(R1) Elemental Impurities.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance finalizes the draft guidance ``Q3D(R1) Elemental Impurities'' published on July 13, 2018. This guidance revises the existing guidance for industry ``Q3D Elemental Impurities'' and provides an updated permitted daily exposure (PDE) for the cadmium inhalation route of exposure. The updated PDE of 3 micrograms ([micro]g)/day is based on a modifying factor approach like that used for calculating the PDEs for the cadmium oral and parenteral routes of exposure. This revised guidance is intended to correct a calculation error in the PDE for cadmium by the inhalation route of exposure.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.'' The meeting will be convened by Duke University's Robert J. Margolis, Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement with FDA. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.

The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the notice that appeared in the Federal Register of April 3, 2019, and extending it indefinitely. The notice announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. In addition, it notified the public that FDA was establishing a docket for public comment on this hearing and that the docket would close on July 2, 2019. On June 20, 2019, a notice that appeared in the Federal Register extended the comment period to July 16, 2019. To provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available, we are reopening the comment period and extending it indefinitely to allow interested parties to continue to comment. We are particularly interested in data that may help to address uncertainties and data gaps related to the safety of cannabidiol (CBD).

The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence. NCI-ComboMATCH trial leadership invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing Next- Generation Sequencing (NGS) assays to participate in the NCI-ComboMATCH trial. In order to support this trial, the designated laboratories participating in NCI-ComboMATCH will identify patients for the specific variants needed for trial eligibility. Laboratories will be required to contact any of the NCTN sites that have activated NCI-ComboMATCH if a specimen sent from one of these sites has a variant(s) that would potentially make the patient eligible for one of the treatment arms.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control.'' This draft guidance replaces the guidance for industry entitled ``Diabetes MellitusEvaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes'' and the draft guidance for industry ``Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention,'' both of which are being withdrawn. This draft guidance outlines the Agency's current recommendations on the evaluation of safety for new drugs and biologics to improve glycemic control in patients with type 2 diabetes. Publication of this guidance is intended to provide clarity on the expectations for the development of drugs and biologics to improve glycemic control and to serve as a focus for commentary and feedback.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period only for the agency information collection activity associated with proposed rulemaking entitled ``Premarket Tobacco Product Applications and Recordkeeping Requirements,'' which appeared in the Federal Register of September 25, 2019. FDA is not reopening the comment period associated with any other aspects of the proposed rulemaking. The Agency is taking this action to seek comment on an additional proposed form to collect information that would be required under certain provisions of the proposed rule. This proposed form would allow for easier identification of each new tobacco product contained in a grouped submission of premarket tobacco product applications (PMTAs). FDA is reopening the comment period only on the proposed agency information collection activity to allow interested persons additional time to submit comments on this form.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect data on human trafficking and other victimization experiences among youth recently or currently involved in the child welfare system. The goal of the one-time survey is to better understand trafficking experiences; to identify modifiable risk and protective factors associated with trafficking victimization; and to inform child welfare policy, programs, and practice.

The Food and Drug Administration (FDA) is announcing the renewal of the Gastrointestinal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Gastrointestinal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 3, 2022.

The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Vancouver, Canada, scheduled for May 23 through 27, 2020. The topics to be addressed at the public meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly Meeting in Vancouver.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Committee on Organ Transplantation (ACOT) has scheduled a public meeting. Information about ACOT and the agenda for this meeting can be found on the ACOT website at https://www.organdonor.gov/about-dot/acot.html.

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 Promoting Adolescent Health through School-Based HIV/STD Prevention Reporting Templates. The data collection is designed to obtain detailed, specific, and consistent reporting to ensure that the Division of Adolescent and School Health (DASH) can determine the context, process and effectiveness of program activities.

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 Community-Based Organizations' Changes in Preparedness and Resources for Support of Biomedical HIV Prevention. The information collection project will be used to assess community-based organizations' (CBOs) awareness of, intentions to provide, and provision of Treatment as Prevention (TasP), non- occupational post-exposure prophylaxis (nPEP), or pre-exposure prophylaxis (PrEP) among clinical and non-clinical CBOs that have received funding from CDC's Division of HIV/AIDS Prevention (DHAP) and those that applied but did not receive funding.