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 2012_register executive 2012-11-28 article Notices D09002ee1c7fc2491 D09002ee1c7fc24e4 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) is announcing the following public meeting entitled "Framework for Pharmacy Compounding: State and Federal Roles." At this public meeting, FDA and State representatives will share their perspectives. Date and Time: The public meeting will be held on December 19, 2012, from 3 p.m. to 5 p.m. Onsite registration will be on a first- come, first-served basis beginning at 2 p.m. Location: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http:/ /www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241740.htm. If you need special accommodations due to a disability, please contact Steve Morin, FDA Office of Special Health Issues, 301-796-0161, email: Steve.Morin@fda.hhs.gov no later than December 14, 2012. Contact Person: Patricia Kuntze, Food and Drug Administration, 10903 New H Ave., Bldg. 32, Rm. 5322, Silver Spring, MD 20993; patricia.kuntze@fda.hhs.gov. Streaming Webcast of the Meeting: This public meeting will also be Webcast. Persons interested in viewing the Webcast should use the access connection at https://collaboration.fda.gov/ pharmacycompounding/. The Webcast will begin on December 19, 2012, at 3 p.m. ET. If you have never attended a Connect Pro meeting before, test your connection at: https://collaboration.fda.gov/common/help/en/support/ meeting--test.htm. Get a quick overview at: http://www.adobe.com/go/ connectpro--overview. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries. If for some reason the test page does not work, that is not a definite indicating factor that the actual Webcast will not work. The test link sometimes appears to be broken on some individuals' computers. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) This Webcast will be closed captioned. Comments: In order to obtain public comment, FDA is also soliciting either electronic or written comments on the issues discussed in section II of this document. The deadline for submitting comments is January 18, 2013. Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments to http://www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when submitting comments on issues as outlined in section II of this document, please identify the issue you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. 77 FR 71009 https://www.govinfo.gov/app/details/FR-2012-11-28/2012-28786 2012-28786 fr28no12-46 4160-01-P Docket No. FDA-2012-N-1154 https://www.govinfo.gov/app/details/FR-2012-11-28/2012-28786 https://www.govinfo.gov/content/pkg/FR-2012-11-28/html/2012-28786.htm https://www.govinfo.gov/content/pkg/FR-2012-11-28/pdf/2012-28786.pdf 2 p. 71009 71010 77 FR 71009 Framework for Pharmacy Compounding: State and Federal Roles; Federal Register Vol. 77, Issue NOTICE 2012-28786 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-N-1154 4160-01-P 2012-28786 Notice of public meeting; request for comments.

The Food and Drug Administration (FDA) is announcing the following public meeting entitled "Framework for Pharmacy Compounding: State and Federal Roles." At this public meeting, FDA and State representatives will share their perspectives. Date and Time: The public meeting will be held on December 19, 2012, from 3 p.m. to 5 p.m. Onsite registration will be on a first- come, first-served basis beginning at 2 p.m. Location: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http:/ /www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241740.htm. If you need special accommodations due to a disability, please contact Steve Morin, FDA Office of Special Health Issues, 301-796-0161, email: Steve.Morin@fda.hhs.gov no later than December 14, 2012. Contact Person: Patricia Kuntze, Food and Drug Administration, 10903 New H Ave., Bldg. 32, Rm. 5322, Silver Spring, MD 20993; patricia.kuntze@fda.hhs.gov. Streaming Webcast of the Meeting: This public meeting will also be Webcast. Persons interested in viewing the Webcast should use the access connection at https://collaboration.fda.gov/ pharmacycompounding/. The Webcast will begin on December 19, 2012, at 3 p.m. ET. If you have never attended a Connect Pro meeting before, test your connection at: https://collaboration.fda.gov/common/help/en/support/ meeting--test.htm. Get a quick overview at: http://www.adobe.com/go/ connectpro--overview. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries. If for some reason the test page does not work, that is not a definite indicating factor that the actual Webcast will not work. The test link sometimes appears to be broken on some individuals' computers. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) This Webcast will be closed captioned. Comments: In order to obtain public comment, FDA is also soliciting either electronic or written comments on the issues discussed in section II of this document. The deadline for submitting comments is January 18, 2013. Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments to http://www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when submitting comments on issues as outlined in section II of this document, please identify the issue you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

Meetings: Framework for Pharmacy Compounding; State and Federal Roles , patricia.kuntze@fda.hhs.gov Steve.Morin@fda.hhs.gov http://www.adobe.com/go/connectpro_overview http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm http://www.fda.gov/NewsEvents/Testimony/ucm327664.htm http://www.fda.gov/NewsEvents/Testimony/ucm327667.htm http://www.regulations.gov https://collaboration.fda.gov/common/help/en/support/meeting_test.htm https://collaboration.fda.gov/pharmacycompounding/ Vol. 77, no. 229 Office of the Federal Register, National Archives and Records Administration 2012-11-28 continuing daily deposited born digital 207 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-11-28 P0b002ee183862111 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28no12 https://www.govinfo.gov/app/details/FR-2012-11-28 https://www.govinfo.gov/content/pkg/FR-2012-11-28/pdf/FR-2012-11-28.pdf https://www.govinfo.gov/content/pkg/FR-2012-11-28/xml/FR-2012-11-28.xml fdlp 70885 71082 DGPO 2012-11-28 2024-06-03 FR-2012-11-28 machine generated eng FR FR-2012-11-28 77 229