Department of Health and Human Services July 30, 2021 – Federal Register Recent Federal Regulation Documents

This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, September 22, 2021. The MEDCAC panel will examine relevant health outcomes in studies for cerebrovascular disease treatment with a particular focus on new technologies of interest to CMS. Given the increased emphasis on new and innovative medical products for treating diseases that have few proven therapies, studies on certain medical technologies have focused on intermediate and surrogate outcomes rather than longer-term data. As a result, there are more frequent evidence gaps with respect to the clinically meaningful health outcomes for CMS beneficiaries, and these gaps impact our assessments of medical technologies. The MEDCAC panel will examine the growing challenges associated with the decreased level of evidence of certain new and innovative technologies. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS about the ideal health outcomes in research studies of cerebrovascular disease treatment technologies, appropriate measurement instruments and follow-up durations to help to provide clarity and transparency of National Coverage Analyses (NCAs). This meeting is open to the public in accordance with the Federal Advisory Committee Act.

The Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), is requesting the Office of Management and Budget (OMB) to approve the Intergovernmental Reference Guide (IRG), with content revisions, for an additional three years. The IRG contains state and tribal child support information that assists child support enforcement (CSE) agencies in the administration of their respective programs. The current OMB approval expires on January 31, 2022.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance \1\ 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.