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 2010_register executive 2010-12-11 article Notices D09002ee1c800948f D09002ee1c80094fb 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 issuing this notice to request that patient and consumer advocacy groups notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Medical Device User Fee Amendments of 2007 (MDUFA) (the Food and Drug Administration Amendments Act of 2007). The statutory authority for MDUFA expires September 30, 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold continued discussions with representatives of patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient and consumer advocacy group representation. 75 FR 77647 https://www.govinfo.gov/app/details/FR-2010-12-13/2010-31160 2010-31160 fr13de10-64 4160-01-P Docket No. FDA-2010-N-0389 https://www.govinfo.gov/app/details/FR-2010-12-13/2010-31160 https://www.govinfo.gov/content/pkg/FR-2010-12-13/html/2010-31160.htm https://www.govinfo.gov/content/pkg/FR-2010-12-13/pdf/2010-31160.pdf 2 p. 77647 77648 75 FR 77647 Medical Device User Fee Program; Meetings on Reauthorization; Request for Notification of Patient and Consumer Advocacy Group Intention to Participate; Federal Register Vol. 75, Issue NOTICE 2010-31160 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2011-01-06 2011-01-13 Docket No. FDA-2010-N-0389 4160-01-P 2010-31160 Notice; request for notification of participation.

The Food and Drug Administration (FDA) is issuing this notice to request that patient and consumer advocacy groups notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Medical Device User Fee Amendments of 2007 (MDUFA) (the Food and Drug Administration Amendments Act of 2007). The statutory authority for MDUFA expires September 30, 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold continued discussions with representatives of patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient and consumer advocacy group representation.

Submit notification of intention to participate by January 6, 2011. The first patient and consumer advocacy group meeting will be held on January 13, 2011, from 9 a.m. to 11 a.m. Meetings will continue at least monthly during reauthorization negotiations with the regulated industry. Cindy Garris, Food and Drug Administration, Center for Devices and Radiological Health 10903 New Hampshire Ave., Bldg. 66, rm. 4610, Silver Spring, MD 20993-0002, 301- 796-5861, FAX: 301-847-8149. Meetings: Medical Device User Fee Program; Request for Notification of Patient and Consumer Advocacy Group Intentions to Participate , MDUFAReauthorization@fda.hhs.gov http://www.fda.gov/MDUFA http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm218250.htm http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm Vol. 75, no. 238 Office of the Federal Register, National Archives and Records Administration 2010-12-13 continuing daily deposited born digital 235 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2010-12-13 P0b002ee180b7ac5b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13de10 https://www.govinfo.gov/app/details/FR-2010-12-13 https://www.govinfo.gov/content/pkg/FR-2010-12-13/pdf/FR-2010-12-13.pdf https://www.govinfo.gov/content/pkg/FR-2010-12-13/xml/FR-2010-12-13.xml fdlp 77521 77747 DGPO 2010-12-11 2024-06-04 FR-2010-12-13 machine generated eng FR FR-2010-12-13 75 238