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

This document corrects technical errors that appeared in the final rule published in the Federal Register on November 19, 2021 entitled ``Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post- Payment Medical Review Requirements'' (referred to hereafter as the ``CY 2022 PFS final rule''). The effective date of the CY 2022 PFS final rule is January 1, 2022.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).'' This guidance identifies the key features of non-clinical and clinical investigational plans used to support investigational device exemption applications, premarket approval applications, De Novo classification requests, and some premarket notification submissions for devices used in the treatment of BPH.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. 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 the audio conference (information below). The audio conference line has 150 ports for callers.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.'' Computational modeling and simulation (CM&S) can be used in a variety of ways in medical device applications, including to perform ``in silico'' device testing or as part of software embedded in a device. This guidance provides a risk-based framework that can be used in the credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. The draft guidance is intended to improve the consistency and transparency of the review of computational modeling evidence. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the draft guidance entitled ``Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' FDA recognizes that it will take time for device manufacturers, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the declared public health emergency (PHE) to normal operations. To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA's general recommendations for a phased transition process with respect to devices that fall within enforcement policies issued during the COVID-19 PHE, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. FDA is concurrently issuing a companion guidance to describe FDA's recommendations for this transition process with respect to devices issued Emergency Use Authorizations (EUAs) during the COVID-19 PHE. This draft guidance is not final nor is it in effect at this time.

The Indian Health Service published a Notice of Funding Opportunity in the Federal Register of November 4, 2021, for the Substance Abuse Prevention, Treatment, and Aftercare grant program. The notice was missing a section in the description of the required Project Narrative that applicants must submit with their application. The Project Narrative will have a fourth section added, Statement of Need, and the page limit for the Project Narrative increased from 15 to 17 pages.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology.'' Physiologic Closed-Loop Control (PCLC) devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during emergency response and medical surge situations. This draft guidance provides technical considerations for PCLC technology in order to promote development and availability of safe and effective PCLC medical devices. This draft guidance is not final nor is it in effect at this time.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF Uniform Project Description (UPD) (OMB #0970-0139, expiration 2/28/2022). There are no changes requested to the form.

The Food and Drug Administration (FDA or Agency) 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3602 and Form FDA 3602A, on which domestic and foreign applicants certify that they qualify as a small business and pay certain medical device user fees at reduced rates.

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.

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 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 2022 Million Hearts[supreg] Hypertension Control Champions Challenge. This program will be used to identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as 2022 Million Hearts[supreg] Hypertension Control Champions.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new system of records to be maintained by the Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE) that will support state child support agencies' enforcement of child support obligations System Number 09-80-0389, ``OCSE Data Center General Support System, HHS/ACF/OCSE.''

The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used for efficacy testing of ectoparasiticide products. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the efficacy of ectoparasiticides on dogs and cats and to facilitate their incorporation into a testing strategy for regulatory purposes.

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.