Department of Health and Human Services October 2021 – Federal Register Recent Federal Regulation Documents

The Office of Child Care (OCC) is requesting a 1-year extension of the form ACF-218: Quality Progress Report (QPR) (OMB #0970-0517, expiration 9/30/2021). There are minor changes requested to the form related to COVID-19 pandemic supplemental funding increases.

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 Application for Training, which supports the management and evaluation of online training and professional development opportunities for public health and health care professionals.

The Department of Health and Human Services (HHS or Department) is proposing to withdraw or repeal a final rule entitled ``Securing Updated and Necessary Statutory Evaluations Timely'' (SUNSET final rule) and published in the Federal Register of January 19, 2021. The SUNSET final rule was originally scheduled to take effect on March 22, 2021. However, after a lawsuit was filed on March 9, 2021, seeking to overturn the SUNSET final rule, HHS issued an administrative delay of effective date that extended the effective date of the SUNSET final rule until March 22, 2022. HHS is now proposing to withdraw or repeal the SUNSET final rule.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ``Targeted Mechanism of Action Presentations in Prescription Drug Promotion.''

The Food and Drug Administration (FDA) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad, and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA's website from the links indicated.

This notice seeks comments on two updated draft recommendations for (1) providing contraception and (2) screening for human immunodeficiency virus (HIV) infection, as part of the HRSA- supported Women's Preventive Services Guidelines (Guidelines). These updated draft recommendations have been developed through a national cooperative agreement, the Women's Preventive Services Initiative (WPSI), by the American College of Obstetricians and Gynecologists (ACOG). Under applicable law, non-grandfathered group health plans and health insurance issuers offering non-grandfathered group and individual health insurance coverage must include coverage, without cost sharing, for certain preventive services, including those provided for in the HRSA-supported Women's Preventive Services Guidelines (Guidelines). The Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury have previously issued regulations, which describe how group health plans and health insurance issuers apply the coverage requirements, including the use of reasonable medical management. (See 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 147.130).

The Food and Drug Administration (FDA, Agency, or we) is proposing to exempt certain categories of biological products from certain reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Specifically, each person who registers with FDA with regard to a drug is required to report annually to FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution; however, certain biological products or categories of biological products may be exempted by order from these reporting requirements if FDA determines that applying such reporting requirements is not necessary to protect the public health. FDA is proposing to exempt the two categories of biological products from these reporting requirements because the Agency has determined that applying such requirements is not necessary to protect the public health.

The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in fiscal year (FY) 2022. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholders' needs.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XENLETA tablets and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the General Services Administration (GSA), announces the availability of the Record of Decision (ROD) for the acquisition of a Site in Mace, West Virginia, and the development of this Site into a replacement for the National Institute for Occupational Safety and Health (NIOSH) Underground Safety Research Program facility (Proposed Action). The acquisition and development will replace the former Lake Lynn Experimental Mine in Fayette County, Pennsylvania, and will support research programs focused on miner health and safety issues. The site to be acquired and developed includes 461.35 acres located off U.S. Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia (Site).

The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) seeks input from Native Hawaiian and Pacific Islander (NHPI) communities, NHPI-serving organizations, and other interested parties regarding efforts of the new Center for Indigenous Innovation and Health Equity (Center). The Center is tasked with supporting education, service and policy development, and research related to advancing sustainable solutions, to address health disparities and advance health equity among NHPI and American Indian/ Alaska Native (AI/AN) populations. This is NOT a solicitation for proposals or proposal abstracts. Please Note: This RFI and notice of a listening session is for planning purposes only. It is not a notice for a proposal and does not commit the federal government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the federal government and will not be returned. All responses will become part of the public record and will not be held confidential. The federal government reserves the right to use the information provided by respondents for purposes deemed necessary and legally appropriate. Respondents are advised that the federal government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents concerning any information submitted. Responses will not be accepted after the due date.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, limited only by the number of audio conference lines and internet conference accesses available, which is 200 combined. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining a teleconference line and/or computer connection (information below).

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 to take this opportunity to comment on proposed information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Research Data Center (RDC) Proposal for Access to Confidential Data for the National Center for Health Statistics (NCHS). The proposed collection will be used to assess researcher's requests for access to confidential NCHS data for their research projects.

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.