Department of Health and Human Services July 5, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDA SubmissionsAmendments to Abbreviated New Drug Applications Under GDUFA.'' This guidance finalizes the October 2017 draft guidance for industry ``ANDA SubmissionsAmendments to Abbreviated New Drug Applications Under GDUFA.'' This guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application's review goal dates. The guidance also describes how FDA will review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the effective date to implement the GDUFA II review goals.

Statement of Organizations, Functions, and Delegations of Authority. The Food and Drug Administration (FDA) is announcing that it has reorganized the Office of Foods and Veterinary Medicine (OFVM), Center for Food Safety and Applied Nutrition (CFSAN) by establishing the new Office of Executive Programs (OEP); realigning OFVM's Office of Coordinated Outbreak Response and Evaluation (CORE) Network along with its Prevention Staff and Response Staff under CFSAN; and retitling the Office of Regulations, Policy, and Social Science (ORPSS) to the Office of Regulations and Policy (ORP). With the retitling to ORP, the Regulations and Special Government Employee Management Staff was retitled to the Regulations Development Staff, and the Government Information Staff was established. This reorganization resulted in the abolishment of OFVM's Executive Secretariat Staff, CFSAN's Office of the Center Director's (OCD) Executive Operations Staff, and the Division of Social Sciences under the former ORPSS. This new organizational structure was approved by the Acting Secretary of Health and Human Services and applicable on December 7, 2017.