Department of Health and Human Services March 22, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry entitled ``Application of the Foreign Supplier Verification Program Regulations to the Importation of Live Animals: Guidance for Industry.'' The purpose of this document is to state FDA's intent to exercise enforcement discretion regarding application of the regulation on foreign supplier verification programs (FSVPs) to importers of certain live animals. The enforcement discretion would apply to importers of live animals that are required to be slaughtered and processed at U.S. Department of Agriculture (USDA) regulated establishments subject to USDA-administered Hazard Analysis and Critical Control Point (HACCP) requirements, or at State-inspected establishments subject to requirements equivalent to the Federal standard.

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Musculoskeletal Health for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2018-0025 in the search field and click ``Search.''

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public symposium entitled ``2018 Center for Biologics Evaluation and Research Science Symposium.'' The purpose of the public symposium is to discuss scientific topics related to the regulation of biologics and highlight science conducted at the Center for Biologics Evaluation and Research (CBER) by showcasing how scientific research informs regulatory decision making and to provide a forum for developing collaborations within FDA and with external organizations. The symposium will include presentations by experts from academic institutions, government agencies, and research institutions.

The Department of Health and Human Services (HHS) proposes to modify current language found in Title 42 of the Code of Federal Regulations which addresses post-approval testing of closed-circuit escape respirators (CCERs). The revised language should clarify that post-approval testing of CCERs may exclude human subject testing and environmental conditioning, at the discretion of the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention, HHS. The revision to the text in this paragraph will clarify the scope of post-approval testing conducted by NIOSH.