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 2013_register executive 2013-04-11 article Notices D09002ee1c7fba202 D09002ee1c7fba281 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 selection of disease areas to be addressed during the first 3 years of Patient-Focused Drug Development. This 5-year initiative is being conducted to fulfill FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). It provides a more systematic approach for the Agency to obtain patients' input on specific disease areas, including their perspectives on their condition, its impact on daily life, and available therapies. FDA selected these disease areas based on a set of selection criteria, the perspectives of the reviewing divisions at FDA, and the public input received on a preliminary set of disease areas published in the Federal Register on September 24, 2012. 78 FR 21613 https://www.govinfo.gov/app/details/FR-2013-04-11/2013-08441 2013-08441 fr11ap13-58 4160-01-P Docket No. FDA-2012-N-0967 https://www.govinfo.gov/app/details/FR-2013-04-11/2013-08441 https://www.govinfo.gov/content/pkg/FR-2013-04-11/html/2013-08441.htm https://www.govinfo.gov/content/pkg/FR-2013-04-11/pdf/2013-08441.pdf 2 p. 21613 21614 78 FR 21613 Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013-2015; Federal Register Vol. 78, Issue NOTICE 2013-08441 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-N-0967 4160-01-P 2013-08441 Notice of Availability.

The Food and Drug Administration (FDA) is announcing the selection of disease areas to be addressed during the first 3 years of Patient-Focused Drug Development. This 5-year initiative is being conducted to fulfill FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). It provides a more systematic approach for the Agency to obtain patients' input on specific disease areas, including their perspectives on their condition, its impact on daily life, and available therapies. FDA selected these disease areas based on a set of selection criteria, the perspectives of the reviewing divisions at FDA, and the public input received on a preliminary set of disease areas published in the Federal Register on September 24, 2012.

Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 1199, Silver Spring, MD 20993, 301-796- 5003, FAX: 301-847-8443, Email: Graham.Thompson@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. Prescription Drug User Fee Act Patient-Focused Drug Development: Disease Areas for Meetings Conducted in Fiscal Years 20132015 , Graham.Thompson@fda.hhs.gov http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm http://www.regulations.gov/#!docketDetail Vol. 78, no. 70 Office of the Federal Register, National Archives and Records Administration 2013-04-11 continuing daily deposited born digital 321 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-04-11 P0b002ee1840fc3ba 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr11ap13 https://www.govinfo.gov/app/details/FR-2013-04-11 https://www.govinfo.gov/content/pkg/FR-2013-04-11/pdf/FR-2013-04-11.pdf https://www.govinfo.gov/content/pkg/FR-2013-04-11/xml/FR-2013-04-11.xml fdlp 21503 21816 DGPO 2013-04-11 2024-06-03 FR-2013-04-11 machine generated eng FR FR-2013-04-11 78 70