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HHS/FDA RIN: 0910-AH36 Publication ID: Fall 2016 
Title: Use of Ozone Depleting Substances(Section 610 Review) 

The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulation (21 CFR 2.125) on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove designations for certain products as essential uses under the Clean Air Act. Essential-use products are exempt from FDA’s ban on the use of CFC propellants in FDA-regulated products and the Environmental Protection Agency’s (EPA’s) ban on the use of CFCs and other ODSs in pressurized dispensers. This action, if finalized, will remove essential use exemptions for sterile aerosol talc administered intrapleurally by thoracoscopy for human use, metered-dose atropine sulfate aerosol human drugs administered by oral inhalation, and anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application. FDA is proposing this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in approved versions that contain ODSs. On June 29, 2015, FDA published a notice and request for comment concerning its tentative conclusion that these products are no longer an essential use under the Clean Air Act (80 FR 36937). The Agency received no comments concerning removal of essential use designations for sterile aerosol talc and metered-dose atropine sulfate, and is proposing to remove these designations by direct final rule and a companion proposed rule in the event adverse comments are received. FDA received one comment concerning removal of anesthetic drugs for topical use in response to its 2015 notice and request for comment, and is proposing to remove this exemption through a separate notice. Because these products are not currently sold in the approved form, no significant economic impact is anticipated.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 21 CFR 2.125   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 335    21 U.S.C. 342    21 U.S.C. 346a    21 U.S.C. 348    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 355    21 U.S.C. 360b    21 U.S.C. 361    21 U.S.C. 371    21 U.S.C. 372    21 U.S.C. 374    15 U.S.C. 402    15 U.S.C. 409   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/00/2016 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Related Agencies: Joint: EPA; 
Agency Contact:
Daniel Orr
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Building 51, Room 5199, 10993 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:240 402-0979