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

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.

The Substance Abuse and Mental Health Services Administration published a correction document in the Federal Register on December 7, 2022 concerning request for comments on Confidentiality of Substance Use Disorder Patient Records published November 22, 2022. The November 22, 2022 publication only listed the Department of Health and Human Services in the headings and contained an incorrect Document Identifier and contact for further information or submission of public comments. The December 7, 2022 document corrected those errors but contained an incorrect contact email address. This document corrects the contact email address. Comments on the information collect request must be received on or before January 23, 2023.

The Food and Drug Administration (FDA, Agency, or we) received objections and requests for a hearing from the International Dairy Foods Association (IDFA) and Chobani, Inc. (Chobani) on the final rule titled ``Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt,'' which published on June 11, 2021. The final rule revoked the standards of identity for lowfat yogurt and nonfat yogurt and amended the standard of identity for yogurt in numerous respects. We are denying the requests for a public hearing and modifying the final rule in response to certain objections. Therefore, the stay of the effectiveness for the final regulation is now lifted.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that TYVASO DPI (treprostinil), approved May 23, 2022, meets the criteria for redeeming a priority review voucher.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring David J. Kempema for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Kempema was convicted of one felony count under Federal law which FDA has determined is for conduct relating to the importation into the United States of a drug or controlled substance. The factual basis supporting Mr. Kempema's conviction is described in further detail below. Mr. Kempema was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of September 14, 2022 (30 days after receipt of the notice), Mr. Kempema had not responded. Mr. Kempema's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

This proposed rule would place new requirements on Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of healthcare data and streamline processes related to prior authorization, while continuing CMS' drive toward interoperability in the healthcare market. This proposed rule would also add a new measure for eligible hospitals and critical access hospitals (CAHs) under the Medicare Promoting Interoperability Program and for Merit-based Incentive Payment System (MIPS) eligible clinicians under the Promoting Interoperability performance category of MIPS. These policies taken together would play a key role in reducing overall payer and provider burden and improving patient access to health information.

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on December 7, 2022. That Notice requires a correction in the SUPPLEMENTARY INFORMATION section.

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.

The Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal 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 Cardiovascular and Renal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2024, expiration date.

The Food and Drug Administration (FDA, Agency, or we) 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.

The Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and Disease Registry (ATSDR) announces the 2023 CDC/ATSDR Tribal Consultation. CDC/ATSDR will host a virtual tribal consultation with American Indian and Alaska Native (AI/AN) Federally Recognized Tribes. The proceedings will be open to the public.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting a three-year extension with proposed revisions to the Hague Child Support Forms (OMB #0970- 0488, expiration February 28, 2023). There are two new forms being incorporated.

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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled U.S. National Authority for Containment of Poliovirus (U.S. NAC) Data Collection Tools. Data collection will capture information relating to a poliovirus containment breach or incident at a U.S. facility and will assist the U.S. NAC in the initial stages of the investigation into the breach, and ensure that facilities have programs in place that align with global poliovirus eradication initiative.