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

This document corrects technical and typographical errors in the final rule that appeared in the August 10, 2022 Federal Register. The final rule was titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non- qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation''.

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 Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on December 12, 2022. The topic for this meeting will be ``NIDDK's Office of Obesity Research: Evolving Concepts in the Heterogeneity of Obesity''. The meeting is open to the public.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, postamendments class III devices with the product code MZF, into class II (special controls), subject to premarket notification. Through this final order, FDA is also adding a new device classification regulation along with special controls that are necessary to provide a reasonable assurance of safety and effectiveness for this device type. The final order reclassifies this device type from class III (premarket approval) to class II (special controls) and will reduce the regulatory burdens associated with these devices because manufacturers will no longer be required to submit a premarket approval application (PMA) for this device type but can instead submit a less burdensome premarket notification (510(k)) and receive clearance before marketing their device.

This final rule implements certain provisions of the Consolidated Appropriations Act, 2021 (CAA). Additionally, we are proposing to delete references to specific Medicare forms from the text of existing regulations at Sec. Sec. 406.7 and 407.11 in order to provide greater administrative flexibility. Finally, this final rule updates the various federal regulations that affect a State's payment of Medicare Part A and B premiums for beneficiaries enrolled in the Medicare Savings Programs and other Medicaid eligibility groups.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Cross Labeling Oncology Drugs in Combination Regimens.'' This guidance describes FDA's current recommendations on including relevant information in labeling for oncology drugs approved for use in combination regimens. This guidance finalizes the draft guidance of the same title issued on November 20, 2020.

The Food and Drug Administration (FDA, the Agency, or we) is requesting comments on the topics discussed at a public workshop entitled ``Advancing Premarket Safety Analytics Workshop'' held on September 14, 2022. The purpose of the public workshop was to present FDA's work and perspective on premarket review of safety data.

ACF, ORR announces the intent to award five single-source awards in the amount of $9,118,248, in multiple states across the country, for Long Term Foster Care (LTFC) services for Unaccompanied Children. ORR proposes to have the recipient conduct the following activities: provide additional capacity for long term placement services. The action is needed because ORR has a pending list with over 300 minors on it who need LTFC placement due to the unanticipated influx of unaccompanied children at the southwestern border in 2021 and the unforeseen arrival of Unaccompanied Afghan Minors (UAM) over the past year.

The Food and Drug Administration (FDA or we) is proposing to amend the color additive regulation to increase the fee for certification services. The change in fees will allow FDA to continue to maintain an adequate color certification program as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act). The fees are intended to recover the full costs of operation of FDA's color certification program.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The final guidance expands the testing scheme for assessing human carcinogenic risk of pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline. The final guidance is intended to offer an integrative approach that provides specific weight of evidence criteria that inform whether a 2-year rat study is likely to add value in completing a human carcinogenicity risk assessment. The Addendum also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model, while all other aspects of the recommendations for high-dose selection in ICH guidance for industry ``S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals'' still apply.

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, 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 studies regarding communications by FDA's Center for Devices and Radiological Health (CDRH). This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health.

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 accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant and Maternal Mortality (ACIMM or Committee) has scheduled a public meeting. Information about ACIMM and the agenda for this meeting can be found on the ACIMM website at https://www.hrsa.gov/advisory-committees/infant- mortality/.

The Social Security Act (the Act) requires us to publish a Medicare final rule no later than 3 years after the publication date of the proposed rule. This document announces an additional 3 month extension of the timeline for publication of a Medicare final rule in accordance with the Act, which allows us to extend the timeline for publication of the ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' final rule under exceptional circumstances.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.

The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee and is seeking nominations for this committee.