3041-AD18 201210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 3041 Consumer Product Safety Commission CPSC Products Containing Imidazolines Equivalent to 0.08 Milligrams or More Pursuant to the Poison Prevention Packaging Act of 1970, the Commission is considering a proposed rule that would require child-resistant ("CR") packaging for any over-the-counter or prescription product containing the equivalent of 0.08 milligrams or more of an imidazoline, a class of drugs that includes tetrahydrozoline, naphazoline, oxymetazoline, and xylometazoline, in a single package. Products containing imidazolines can cause serious adverse reactions, such as central nervous system ("CNS") depression, decreased heart rate, and depressed ventilation in children treated with these drugs or who accidentally ingest them. CPSC staff submitted a briefing package on the proposed rule for Commission consideration on January 11, 2012. The Commission found preliminarily that availability of 0.08 milligrams or more of an imidazoline in a single package, by reason of its packaging, is such that special packaging is required to protect children under 5-years-old from serious personal injury or illness due to handling, using, or ingesting such a substance. On January 18, 2012, the Commission voted unanimously to publish the proposed rule in the Federal Register. The proposed rule published on January 25, 2012, and the comment period ended on April 9, 2012. Staff is preparing for Commission consideration a briefing package on a final rule. Substantive, Nonsignificant First Time Published in The Unified Agenda Final Rule Stage Undetermined No Not Yet Determined Not Yet Determined No Staff Sent Briefing Package to Commission 01/11/2012 Commission Decision 01/18/2012 NPRM 01/25/2012 77 FR 3646 NPRM Comment Period End 04/09/2012 Commission Decision 12/00/2012 Undetermined Undetermined No No Cheryl Osterhout 3041 Consumer Product Safety Commission CPSC 301 504-7290 costerhout@cpsc.gov Directorate for Health Sciences, 4330 East West Highway, Bethesda MD 20814