Department of Health and Human Services September 7, 2017 – Federal Register Recent Federal Regulation Documents

The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2017 Performance Review Board.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Guidance for Industry.'' The guidance document provides establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015.