Department of Health and Human Services November 7, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on a draft document that details best practices for drug safety surveillance entitled ``Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.'' The 21st Century Cures Act (Cures Act) was enacted on December 13, 2016, and requires that FDA make publicly available on its internet website best practices for drug safety surveillance activities. The draft document sets forth risk-based principles by which FDA conducts ongoing postmarketing safety surveillance for drug and biological products to address the Cures Act requirements. FDA is seeking public comment on the draft best practices in drug and biological product postmarket safety surveillance.

Findings of research misconduct have been made against Erin N. Potts Kant (Respondent), former Clinical Research Coordinator, Division of Pulmonary, Allergy, and Critical Care Medicine (PMCCM), Duke University School of Medicine (Duke). Ms. Potts Kant engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants HL105702, HL005009, HL058795, HL036982, HL044984, HL062472, HL067021, HL067281, HL067669, HL068072, HL073896, HL077291, HL077763, HL079915, HL081285, HL081763, HL082504, HL084123, HL084917, HL085655, HL086887, HL087094, HL090146, HL090265, HL098099, HL091140, HL091335, HL091642-02, HL092994, HL073907, and HL111151; National Institute of Allergy and Infectious Diseases (NIAID), NIH, grants AI081672, AI089756, AI068822, AI056101, AI067798, AI074751, AI050021, AI058161, AI064789, and AI052201; National Institute on Environmental Health Sciences (NIEHS), NIH, grants ES020426, ES007943, ES011961, ES012496, ES016836, ES012717, ES015675, ES016126, ES016347, ES016659, and ES020350; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grants DK050814, DK077159, and DK077307; National Cancer Institute (NCI), NIH, grants CA142842 and CA092656; National Center for Research Resources (NCRR), NIH, grants RR005959 and RR024127; and National Institute of Child Health and Human Development (NICHD), NIH, grant HD043728. The administrative actions, including permanent debarment, were implemented beginning on October 1, 2019, and are detailed below.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 people and the audio conference line has 150 ports for callers. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below).