Department of Health and Human Services March 5, 2020 – Federal Register Recent Federal Regulation Documents

Through this Request for Information (RFI), the Administration for Children and Families (ACF), in the U.S. Department of Health and Human Services (HHS), seeks to further the development of employment programs for nonresident parents by soliciting information and recommendations from a broad array of stakeholders in the public and private sectors, including state, regional, tribal, and local areas. The Foundations for Evidence-Based Policymaking Act of 2018 (Evidence Act) requires federal agencies to develop evidence-building plans to identify and address policy questions relevant to programs, policies, and regulations of the agency. In this vein, ACF will analyze information collected from this RFI to continue developing a learning and action agenda to better understand the effectiveness of employment programs for nonresident parents.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``The `Deemed To Be a License' Provision of the BPCI Act: Questions and Answers.'' This guidance is intended to provide answers to common questions about FDA's implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the March 23, 2020, transition date and provide further clarity regarding the Agency's implementation of this statutory provision. This guidance finalizes the draft guidance of the same title issued on December 12, 2018.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a guidance for industry entitled ``Exocrine Pancreatic Insufficiency Drug ProductsSubmitting NDAs,'' which was issued in 2006. The guidance set forth the Agency's thinking on data and information that may support a new drug application (NDA) for a proposed pancreatic enzyme product (PEP) that contains pancreatin or pancrelipase and is intended for the treatment of exocrine pancreatic insufficiency (EPI). FDA is withdrawing the guidance because an NDA for such a product may not be submitted after March 23, 2020. Sponsors interested in submitting a biologics license application (BLA) for a proposed PEP should contact the Agency with any questions.