Department of Health and Human Services June 2023 – Federal Register Recent Federal Regulation Documents

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting one administrative supplement in scope of the parent award to the State Opioid Response (SOR)/Tribal Opioid Response (TOR) Technical Assistance Grant recipient, the American Academy of Addiction Psychiatry (AAAP) funded in FY 2022 under Notice of Funding Opportunity (NOFO) TI-22-007 to provide training and technical assistance to federally-recognized Tribes and Tribal organizations.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send 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 Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by PHM Brands, proposing that the food additive regulation for chlorine dioxide be amended to provide for an additional method for producing the additive.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Daylen Diaz from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Daylen Diaz was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Daylen Diaz was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of February 26, 2023 (30 days after receipt of the notice), Ms. Diaz had not responded. Ms. Diaz' failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.

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.

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.

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 Administration for Community Living (ACL) within The Department of Health and Human Services (``the Department'' or HHS) is issuing this notice of proposed rulemaking (NPRM) to modernize the implementing regulations of the Older Americans Act of 1965 (``the Act'' or OAA), which have not been substantially altered since their promulgation in 1988. These changes advance the policy goals of the Older Americans Act as articulated by Congress, including equity in service delivery, accountability for funds expended, and clarity of administration for the Administration for Community Living and its grantees. Our proposals will ultimately facilitate improved service delivery and enhanced benefits for OAA participants, particularly those in greatest economic need and greatest social need consistent with the statute.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a draft guidance document titled, ``Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions.''

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 NCEZID Rapid Message Testing & Development System. This collection will enable the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) to test health messages and gather information to inform the development of health messages.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send 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 Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Content of Premarket Submissions for Device Software Functions.'' This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of safety and effectiveness of device software functions, which are functions that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This document replaces FDA's ``Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'' issued on May 11, 2005, and updates FDA's thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Sports, Fitness & Nutrition (PCSFN) will hold its annual meeting. The meeting will be open to the public.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Evaluation of Dietary Protein Intake Requirements, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.