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

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.

In accordance with the Federal Advisory Committee Act, the CDC and the Health Resources and Services Administration (HRSA), announces the following meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). This meeting is open to the public, limited only by audio and web conference lines available, by accessing the (information below). Time will be available for oral public comment. Persons who desire to make an oral statement, may request it at the time of the public comments period on July 21, 2020 at 3:45 p.m., EDT. Written comments received in advance of the meeting will be included in the official record of the meeting.

In accordance with an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020, from June 18, 2021, to October 16, 2021.

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.

We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2021 and to implement certain recent legislation. We also are proposing to make changes relating to Medicare graduate medical education (GME) for teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2021. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2021. In this FY 2021 IPPS/LTCH PPS proposed rule, we are proposing changes to the new technology add-on payment pathway for certain antimicrobial products and other changes to new technology add-on payment policies, and to collect market-based rate information on the Medicare cost report for cost reporting periods ending on or after January 1, 2021, and requesting comment on a potential market based MS-DRG relative weight methodology beginning in FY 2024 that we may adopt in this rulemaking. We are proposing to establish new requirements or revise existing requirements for quality reporting by acute care hospitals and PPS- exempt cancer hospitals. We also are proposing to establish new requirements and revise existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs. We are providing estimated and newly established performance standards for the Hospital Value-Based Purchasing (VBP) Program, and proposing updated policies for the Hospital Readmissions Reduction Program and the Hospital- Acquired Condition (HAC) Reduction Program.

The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of February 14, 2020, entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration; Draft Guidance for Industry.'' This supplemental draft guidance document, when finalized, will help food facilities that manufacture, process, pack, or hold food, and that are required to register under the Federal Food, Drug, and Cosmetic Act comply with the requirements of our regulation entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.'' FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services is initiating the development of another set of Toxicological Profiles. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List (available at https://www.atsdr.cdc.gov/ SPL/). ATSDR also accepts nominations for non-Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) substances that may have public health implications, on the basis of ATSDR's authority to prepare Toxicological Profiles for substances not found at sites on the CERCLA National Priorities List. For more information on the CERCLA National Priorities List, visit https://www.epa.gov/superfund/superfundnational-priorities-li st-npl. The agency will do so in order to establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances, to respond to requests for consultation, and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.

The Administration on Children, Youth and Families (ACYF), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new descriptive study, Adoption Call to Action (ACTA) Data Collection.

The Office of Refugee Resettlement (ORR) is requesting a 3- year extension of the application and Withdrawal of Application or Declination of Placement Form for the Unaccompanied Refugee Minors (URM) Program. Proposed revisions to each instrument are minimal. These forms were previously approved under OMB #0970-0498, expiration 7/31/ 2020. ORR is currently seeking a new OMB number specific to these forms, as they were previously approved as part of another information collection package for ORR's Unaccompanied Alien Children's program.

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.

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.

This notice announces the application of AABB for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant AABB deeming authority for a period of 4 years. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program.

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.