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Proposed RuleSignificantE7-153722007-08-07

Use of Ozone-Depleting Substances; Removal of Essential-Use Designations; Extension of Comment Period

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA) is extending to September 10, 2007, the comment period for the proposed rule published in the Federal Register of June 11, 2007 (72 FR 32030). The proposed rule would amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for oral pressurized metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. FDA is taking this action in response to a request for an extension.

Action & Dates

Action
Proposed rule, extension of comment period.
Dates
Submit written or electronic comments by September 10, 2007.

CFR References

Public Comment

Comments Close
2007-09-10

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 2 [Docket No. 2006N-0454] RIN 0910-AF93 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule, extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is extending to September 10, 2007, the comment period for the proposed rule published in the Federal Register of June 11, 2007 ( 72 FR 32030 ). The proposed rule would amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for oral pressurized metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. FDA is taking this action in response to a request for an extension. DATES: Submit written or electronic comments by September 10, 2007. ADDRESSES: You may submit comments, identified by Docket No. 2006N-0454, by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. Agency Web site: http://www.fda.gov/​dockets/​ecomments . Follow the instructions for submitting comments on the agency Web site. Written Submissions Submit written submissions in the following ways: FAX: 301-827-6870. Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Docke

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Related Documents

Other Federal Register documents from the same docket.

Full Document

Citation: 72 FR 44037