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CHPA requests that FDA publish a statement of enforcement policy expressly permitting manufacturers of single-ingredient acetaminophen OTC drugs subject to the ongoing internal analgesic, antipyretic, and antirheumatic monograph proceedings to including labeling on products that provide instructions for use in children aged six months to two years.

CHPA comments on the “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108.”

CHPA candidate submission for consideration to serve as the non-voting industry representative on the FDA Pediatric Advisory Committee.

The members of the stakeholder selection committee respectfully submit these candidates to serve as the non-voting industry representative and alternate (as needed) for the FDA Pediatric Advisory Committee.

Briefing book for the Joint Meeting of the Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee, May 17-18, 2011.