Department of Health and Human Services December 22, 2021 – Federal Register Recent Federal Regulation Documents

This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 9, 2021 titled ``Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting Requirements for Long-Term Care Facilities''.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Validation and Verification of Analytical Testing Methods used for Tobacco Products'' and requesting comments, including scientific and other information, concerning the recommendations set forth in the draft guidance. The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test methods, including analytical testing of tobacco product constituents, ingredients, and additives, as well as stability testing of tobacco products. This draft guidance would help industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products.

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, Agency, or we) has determined that Alcohol and Dextrose Injection, 5 milliliters (mL)/100 mL, 5 gram (g)/100 mL; and Alcohol and Dextrose Injection, 10 mL/100 mL, 5 g/100 mL, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for Alcohol and Dextrose Injection, 5 mL/100 mL, 5 g/100 mL; and 10 mL/100 mL, 5 g/100 mL.