Department of Health and Human Services December 18, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) 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 Administration for Children and Families' (ACF) Office of Child Support Enforcement (OCSE) is requesting an update to the Advance Planning Document (APD) process (OMB #0970-0417). OCSE proposes revisions to the annual burden estimates to reflect an increase in the number of states seeking approval to implement modernization solutions in efforts to replace antiquated legacy child support enforcement systems and to address an excess demand for emergency funding requests due to the impacts of the COVID-19 pandemic.

The Office of Refugee Resettlement (ORR) Administration for Children and Families (ACF), Department of Health and Human Services (HHS), is proposing to continue to collect information that will allow Unaccompanied Alien Children (UAC) Program to provide services to UAC as required by statute and ORR policy. These information collections were originally approved under emergency approval for 6 months. This request is to continue data collection. Information collections related to other aspects of the UAC Programs, such as sponsorship and health care, are covered under OMB Numbers 0970-0278, 0970-0385, 0970-0466, 0970-0490, 0970-0498, 0970-0509, and 0970-0543.

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 Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the proposed rule and reopening the comment period for the information collection related to the proposed rule entitled ``Requirements for Additional Traceability Records for Certain Foods'' that appeared in the Federal Register of September 23, 2020. We are taking this action in response to a request from stakeholders to extend the comment period to allow additional time for interested persons to submit comments on the proposed rule. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a public docket to obtain comment on non-substantive changes to three data collections conducted by CDC's National Center for Health Statistics (NCHS). Although CDC has already obtained approval from the Office of Management and Budget (OMB) under the Paperwork Reduction Act on these non-substantive changes, CDC is requesting public comment on these non-substantive changes.

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 ``Examining Safety and Health Among Aviation Industry Workers in Alaska: A Survey.'' The goals of this survey are to collect information on injuries and illness; identify the perceived safety and health needs and concerns; develop safety guidance; and assist in generating hypotheses for future research on health and safety topics among Alaska aviation industry workers.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``The Use of an Alternate Name for Potassium Chloride in Food Labeling.'' This guidance explains our intent to exercise enforcement discretion for the declaration of the name ``potassium salt,'' as an alternative to ``potassium chloride,'' in the ingredient statement on the labels of foods that contain potassium chloride as an ingredient.

This proposed rule would place new requirements on state Medicaid and CHIP fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of health care data, and streamline processes related to prior authorization, while continuing CMS' drive toward interoperability, and reducing burden in the health care market. In addition, on behalf of the Department of Health and Human Service (HHS), the Office of the National Coordinator for Health Information Technology (ONC) is proposing the adoption of certain specified implementation guides (IGs) needed to support the proposed Application Programming Interface (API) policies included in this rule. Each of these elements plays a key role in reducing overall payer and provider burden and improving patient access to health information.