Department of Health and Human Services January 18, 2022 – Federal Register Recent Federal Regulation Documents

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 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 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 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.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 22, 2021. The document announced the withdrawal of approval of 216 abbreviated new drug applications (ANDAs) from multiple applicants, as of November 22, 2021. The document was published with an incorrect date. In addition, the document indicated that FDA was withdrawing approval of ANDA 075941, Strontium Chloride SR-89 Injection, 1 millicurie/milliliter, held by Bio-Nucleonics, Inc., 1600 Market St., Suite 13200, Philadelphia, PA 19103, for repeated failure to submit annual reports. Before FDA withdrew the approval of this ANDA, the application holder informed FDA that it submitted annual reports for ANDA 075941. Therefore, FDA rescinds its withdrawal of approval of ANDA 075941. The approval of ANDA 075941 is still in effect.

The Food and Drug Administration (FDA or we) is amending the requirements that specify the analytical method FDA uses to determine the concentration of sulfites in food. This action, among other things, provides a new analytical method that can be used as an alternative to the existing analytical method and will help improve the efficiency of FDA testing for sulfites in food.

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.

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 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 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.