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

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection activity associated with our food labeling regulations.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Nonprescription Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of rapid response surveys to obtain data on safety information to support quick turnaround decision making about potential safety problems or risk management solutions from healthcare professionals, hospitals, and other user facilities (i.e., nursing homes, etc.); consumers; manufacturers of biologics, drugs, food, dietary supplements, cosmetics, animal food and feed, and medical devices; distributors; and importers, when FDA must quickly determine whether or not a problem with a biologic, drug, food, cosmetic, dietary supplement, animal food and feed, or medical device impacts the public health.

The Secretary of Health and Human Services (Secretary) announces a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The ISUDCC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory- councils/meetings. The meeting will include information on support for the mission and work of the Committee, federal advances to address challenges in substance use disorders (SUD); non-federal advances to address challenges in SUD. Committee Name: Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). Date/Time/Type: February 28, 2020/9:30 a.m.TBD (ET)/OPEN.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Advancing Animal Models for Antibacterial Drug Development.'' The purpose of the public workshop is to discuss progress and challenges in the development of various animal models for serious infection funded by FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) to facilitate antibacterial drug development, and to discuss ideas for future research. This public workshop is a follow up to the FDA public workshop held on March 1, 2017, entitled ``Current Status and Future Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa.''