United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-10-26 article Rules and Regulations D09002ee1c7f34539 D09002ee1c7f345ca United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as "essential uses" under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. FDA is taking this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs. 81 FR 74298 https://www.govinfo.gov/app/details/FR-2016-10-26/2016-25851 2016-25851 fr26oc16-10 RIN 0910-AH36 4164-01-P Docket No. FDA-2015-N-1355 https://www.govinfo.gov/app/details/FR-2016-10-26/2016-25851 https://www.govinfo.gov/content/pkg/FR-2016-10-26/html/2016-25851.htm https://www.govinfo.gov/content/pkg/FR-2016-10-26/pdf/2016-25851.pdf Administrative Practice and Procedure Cosmetics Drugs Foods 5 p. 74298 74302 81 FR 74298 Title 21 Part 2 21 CFR Part 2 RIN 0910-AH36 Use of Ozone-Depleting Substances; Federal Register Vol. 81, Issue RULE 2016-25851 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-02-23 2016-12-27 Docket No. FDA-2015-N-1355 4164-01-P 2016-25851 Direct final rule.

The Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as "essential uses" under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. FDA is taking this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs.

This direct final rule is effective February 23, 2017. Submit either electronic or written comments on the direct final rule by December 27, 2016. If FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993, 240-402-0979, daniel.orr@fda.hhs.gov. Administrative Practice and Procedure Cosmetics Drugs Foods Use of Ozone-Depleting Substances , daniel.orr@fda.hhs.gov http://listings.findthecompany.com/l/12165972/Bryan-Corporation-in-Woburn-MA http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf http://www.regulations.gov Vol. 81, no. 207 Office of the Federal Register, National Archives and Records Administration 2016-10-26 continuing daily deposited born digital 388 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-10-26 P0b002ee191e0cf54 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr26oc16 https://www.govinfo.gov/app/details/FR-2016-10-26 https://www.govinfo.gov/content/pkg/FR-2016-10-26/pdf/FR-2016-10-26.pdf https://www.govinfo.gov/content/pkg/FR-2016-10-26/xml/FR-2016-10-26.xml fdlp 74279 74656 DGPO 2016-10-26 2024-06-01 FR-2016-10-26 machine generated eng FR FR-2016-10-26 81 207