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

The Food and Drug Administration (FDA, the Agency, or we) is correcting a proposed rule that published in the Federal Register of July 24, 2020. That proposed rule proposes to establish requirements for the deadline and contents of submission in an annual summary. We are placing a corrected copy of the proposed rule in the docket.

The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidance documents have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of August 13, 2020. The final rule establishes requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients.

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 Food and Drug Administration (FDA or the Agency) is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2023 through 2027 (MDUFA V). MDUFA authorizes FDA to collect user fees to support the process for the review of medical device applications. The current legislative authority for MDUFA expires after September 30, 2022, and new legislation will be required for FDA to continue collecting user fees for the medical device program in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin MDUFA reauthorization by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization, providing a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to MDUFA, and publishing the comments on FDA's website.

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 Medical Monitoring Project (MMP). The purpose of this data collection is to describe the health-related behaviors, experiences and needs of adults diagnosed with HIV in the United States. Data will be used to guide national and local HIV- related service organization and delivery, and monitor receipt of HIV treatment and prevention services and clinical outcomes.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Council on Blood Stem Cell Transplantation (ACBSCT) has scheduled a public meeting. Information about ACBSCT and the agenda for this meeting can be found on the ACBSCT website at https://bloodstemcell.hrsa.gov/about/advisory- council.

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.

The Secretary of Health and Human Services announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. Agenda with call-in information will be posted on SAMHSA's website prior to the meeting at: https://www.samhsa.gov/about-us/ advisory-councils/meetings. The meeting will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).

The Administration for Children and Families' (ACF) Office of Child Support Enforcement (OCSE) is requesting an update to the existing data collection for the Advance Planning Document (APD) process (OMB #0970-0417). OCSE proposes revisions to the annual burden estimates to reflect an increase in the number of states seeking approval to implement modernization solutions in efforts to replace antiquated legacy child support enforcement systems and to address an excess demand for emergency funding requests due to the impacts of the COVID-19 pandemic.

In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that the Advisory Committee on Organ Transplantation (ACOT) has been renewed. The effective date of the renewed charter is August 31, 2020.

HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS (Secretary). HRSA is seeking nominations of qualified candidates for appointment to five positions on the Committee for terms of up to 4 years.