Department of Health and Human Services June 1, 2020 – Federal Register Recent Federal Regulation Documents

This document corrects technical errors that appeared in the notice published in the Federal Register on April 1, 2020 entitled ``Medicare and Medicaid Programs; Application from the Joint Commission (TJC) for Continued Approval of its Home Health Agency Accreditation Program.''

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information in the FDA publication, ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (commonly known as the ``Orange Book''). We are soliciting comments on the types of patents currently listed in the Orange Book and the impact that any change to current patent listing practices may have on drug product development. This notice is not intended to communicate our regulatory expectations on these issues but is instead intended to seek early input from the public to inform further regulatory action if determined to be appropriate.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Orange BookQuestions and Answers.'' This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). This guidance provides answers to commonly asked questions FDA has received from interested parties regarding the Orange Book.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #240 entitled ``Proprietary Names for New Animal Drugs.'' This guidance provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand the drug. This guidance proposes a framework for evaluating proposed proprietary names before submitting them for review by the Center for Veterinary Medicine (CVM or we). It also explains how new animal drug sponsors can request that CVM evaluate a proposed proprietary name.

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) is accepting mandatory formula grant applications and State Plans from states and territories for the development of and implementation for Title V State Sexual Risk Avoidance Education (SRAE) Program. The Title V State SRAE Funding Opportunity Announcement sets forth the application requirements for the receipt of the following documents from applicants and awardees: Application, State Plan, and Performance Progress Report.