Department of Health and Human Services September 9, 2019 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) seeks nominations of qualified candidates to serve as members of the President's Council on Sports, Fitness & Nutrition Science Board.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Acceptance Review for De Novo Classification Requests.'' The purpose of this guidance is to explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. This guidance discusses De Novo acceptance review policies and procedures, ``Refuse to Accept'' principles, and the elements of the De Novo Acceptance Checklist and the Recommended Content Checklist and is being issued to be responsive to an explicit deliverable identified in the Medical Device User Fee Amendments of 2017 (MDUFA IV).

The Food and Drug Administration (FDA or Agency) has determined that CALCIMAR (calcitonin salmon) Injection, 200 International Units per milliliter (IU/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for CALCIMAR (calcitonin salmon) Injection, 200 IU/mL, if all other legal and regulatory requirements are met.