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CPSC

RIN: 3041-AD18

Publication ID: 2012

Title: ●Products Containing Imidazolines Equivalent to 0.08 Milligrams or More
Abstract: 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.
Agency: Consumer Product Safety Commission(CPSC)	Priority: Substantive, Nonsignificant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Final Rule Stage
Major: Undetermined	Unfunded Mandates: No
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Not Yet Determined

Legal Deadline: None

Timetable:

Action	Date	FR Cite
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

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: Undetermined
Federalism: Undetermined
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Cheryl Osterhout Project Manager Consumer Product Safety Commission Directorate for Health Sciences, 5 Research Place, Rockville, MD 20850 Phone:301 987-2572 Email: costerhout@cpsc.gov