Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine); Public Meeting; Extension of Comment Period

Streszczenie

The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on a proposed rule that would amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designation for oral pressurized metered-dose inhalers (MDIs) containing epinephrine. The proposed rule was published in the Federal Register of September 20, 2007 (72 FR 53711). Information from the public meeting, which is required by agency regulations, will be considered in finalizing the rulemaking. In addition, the comment period on the proposed rule is being extended to December 19, 2007, to accommodate the meeting and to provide a short period after the meeting to receive additional comments.