Department of Health and Human Services January 8, 2020 – Federal Register Recent Federal Regulation Documents

The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing data collection activities conducted for the Next Generation of Enhanced Employment Strategies (NextGen) Project. The objective of this project is to identify and rigorously evaluate innovative interventions designed to promote employment and economic security among low-income individuals with complex challenges to employment. The project will include an experimental impact study, descriptive study, and cost study.

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ``Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry'' that appeared in the Federal Register of October 25, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 19 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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, the Agency, or we) is announcing the following public meeting entitled ``Modernizing FDA's Data Strategy.'' The purpose of the public meeting and the request for comments is to discuss possible Agency level approaches to modernizing FDA's data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics.

The Food and Drug Administration (FDA) is announcing the revocation of three Emergency Use Authorizations (EUAs) (the Authorizations) issued to OraSure Technologies, Inc. (OraSure) for the OraQuick Ebola Rapid Antigen Test used with whole blood specimens; OraSure for the OraQuick Ebola Rapid Antigen Test used with cadaveric oral fluid swab specimens; and DiaSorin Inc. (DiaSorin) for the LIAISON XL Zika Capture IgM II assay. FDA revoked both of OraSure's Authorizations on October 10, 2019, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in consideration of a De Novo classification request granted to OraSure for the OraQuick Ebola Rapid Antigen Test on October 10, 2019. FDA revoked DiaSorin's Authorization on October 28, 2019, under the FD&C Act, in consideration of the premarket clearance of DiaSorin's LIAISON XL Zika Capture IgM II assay, which FDA determined to be substantially equivalent to a legally marketed class II predicate device on October 28, 2019. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.