Department of Health and Human Services September 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) has determined that bacitracin for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for bacitracin for injection.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold an in- person meeting. The meeting will be open to the public and public comment will be heard during the meeting.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to specify the deadline and content for submission of an annual summary of investigational drugs supplied under the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act) and the uses for which the investigational drugs were supplied. This final rule implements a provision in the Right to Try Act that requires sponsors and manufacturers who provide an ``eligible investigational drug'' under the provisions of the Right to Try Act to submit to FDA an annual summary of such use, and directs FDA to specify by regulation the deadline of submission.

Each agency is required to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more Senior Executive Service (SES) Performance Review Boards (PRBs). The PRB shall review and evaluate the initial summary rating of a senior executive's performance, the executive's response, and any higher-level review's comments on the initial summary rating. In addition, the PRB will review and recommend executive performance bonuses and pay increases.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REYVOW and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Policy for Monkeypox Tests To Address the Public Health Emergency.'' On August 4, 2022, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency related to monkeypox. Monkeypox virus is a zoonotic infection (a virus transmitted to humans from animals), caused by Orthopoxvirus genus of the Poxviridae family similar to variola virus (the causative agent of smallpox), and can spread to humans. Since early May 2022, cases of monkeypox have been reported from countries where the disease is not endemic and continue to be reported in several endemic countries. Rapid detection of monkeypox cases in the United States requires wide availability of diagnostic testing to control the emergence of this contagious infection. This guidance describes FDA's review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests, as well as FDA's enforcement policies for various monkeypox tests. The guidance document has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule amending its public information regulations. The final rule revises the current regulations to incorporate changes made to the Freedom of Information Act (FOIA) by the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act) and the FOIA Improvement Act of 2016 (FOIA Improvement Act). Additionally, the final rule updates the current regulations to reflect changes to the organizational structure of FDA, to make the FOIA process easier for the public to navigate, and to make provisions clearer.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Prior Notice of Imported Food Questions and Answers; Draft Guidance for Industry (Edition 4).'' The draft guidance adds three additional questions. One question relates to any effect systems recognition or equivalency determinations have on prior notice requirements. The other two questions relate to FDA's notice to a submitter of prior notice of an FDA refusal for inadequate prior notice or hold if the food article is from a foreign facility that is not registered, and address the timeframe for making requests for FDA review of such a refusal or hold. FDA is also making other technical and editorial changes.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF-204 (Annual MOE Report; OMB #0970-0248, expiration November 30, 2022). There are no changes requested to this information collection.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act. On August 9, 2022, the Secretary determined pursuant to his authority under the FD&C Act that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus. On the basis of this determination, he declared on September 7, 2022 that circumstances exist justifying authorizations of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to the FD&C Act.

HHS proposes to exempt certain records in an existing system of records maintained by OCSE within ACF from the accounting, access, and amendment requirements of the Privacy Act. The affected system of records is OCSE Federal Case Registry of Child Support Orders, HHS/ACF/ OCSE, System No. 09-80-0385. Only case files marked with the Family Violence Indicator (FVI) are proposed to be exempted, to align with a restriction in the Social Security Act which prohibits disclosure of case files marked with the FVI to anyone other than a court or agent of a court, to avoid harm to the custodial parent or the child of such parent. Elsewhere in this issue of the Federal Register, HHS/ACF has published an updated system of records notice (SORN) for system 09-80- 0385 for public notice and comment.

Additional grant funds were provided to two Health Center Program award recipients in Lexington, Kentucky and Worcester, Massachusetts with periods of performance ending in fiscal year (FY) 2022 to extend their periods of performance by up to 7 months to ensure the ongoing delivery of services until a new award could be made.

The Office of Planning, Research, and Evaluation (OPRE), Administration for Child and Families (ACF) is proposing an information collection activity for the Culture of Continuous Learning Project (CCL). The goal of the project is to assess the feasibility of implementing continuous quality improvement methods in early care and education (ECE) programs and systems to support the use and sustainability of evidence-based practices.