Department of Health and Human Services August 6, 2020 – Federal Register Recent Federal Regulation Documents

In compliance with the requirements of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH), Office of Disease Prevention (ODP) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2020 Performance Review Board.

The Food and Drug Administration (FDA) is correcting a proposed order to revoke the approved method for detecting residues of carbadox, a carcinogenic new animal drug used in swine feed. The document was published with an incorrect docket number. This document corrects that error.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Inorganic Arsenic in Rice Cereals for Infants: Action Level.'' The guidance identifies for industry an action level for inorganic arsenic in rice cereals for infants that is intended to help protect public health and is achievable with the use of current good manufacturing practices. It also describes our intended sampling and enforcement approach. Thus, the guidance finalizes the approach presented in the draft guidance issued in 2016.

The Food and Drug Administration (FDA) 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 Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled ``Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.'' Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct is on the FDA's ``Postmarketing Requirements and Commitments: Reports'' web page.

This proposed rule would establish a policy concerning the treatment of patient days associated with persons enrolled in a Medicare Part C (also known as ``Medicare Advantage'') plan for purposes of calculating a hospital's disproportionate patient percentage for cost reporting periods starting before fiscal year (FY) 2014 in response to the ruling in Azar v. Allina Health Services, 139 S. Ct. 1804 (June 3, 2019).