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 2013-06-05 article Notices D09002ee1c7fb6718 D09002ee1c7fb6784 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 a public meeting and an opportunity for public comment on Patient-Focused Drug Development for lung cancer. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of lung cancer on daily life as well as the available therapies for lung cancer. 78 FR 33851 https://www.govinfo.gov/app/details/FR-2013-06-05/2013-13243 2013-13243 fr05jn13-59 4160-01-P Docket No. FDA-2013-N-0596 https://www.govinfo.gov/app/details/FR-2013-06-05/2013-13243 https://www.govinfo.gov/content/pkg/FR-2013-06-05/html/2013-13243.htm https://www.govinfo.gov/content/pkg/FR-2013-06-05/pdf/2013-13243.pdf 2 p. 33851 33852 78 FR 33851 Lung Cancer Patient-Focused Drug Development; Public Meeting; Federal Register Vol. 78, Issue NOTICE 2013-13243 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2013-07-29 2013-06-28 Docket No. FDA-2013-N-0596 4160-01-P 2013-13243 Notice of public meeting; request for comments.

The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for lung cancer. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of lung cancer on daily life as well as the available therapies for lung cancer.

The public meeting will be held on June 28, 2013, from 8:30 a.m. to 12:30 p.m. Registration to attend the meeting must be received by June 19, 2013 (see SUPPLEMENTARY INFORMATION for instructions). Submit electronic or written comments by July 29, 2013. 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- 0684, FAX: 301-847-8443, email: graham.thompson@fda.hhs.gov. Meetings: Lung Cancer Patient-Focused Drug Development , graham.thompson@fda.hhs.gov PatientFocused@fda.hhs.gov http://patientfocusedlungcancer.eventbrite.com http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm http://www.fda.gov/Forindustry/UserFees/PrescriptionDrugUserFee/ucm353273.htm www.regulations.gov Vol. 78, no. 108 Office of the Federal Register, National Archives and Records Administration 2013-06-05 continuing daily deposited born digital 271 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-06-05 P0b002ee184f6f533 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05jn13 https://www.govinfo.gov/app/details/FR-2013-06-05 https://www.govinfo.gov/content/pkg/FR-2013-06-05/pdf/FR-2013-06-05.pdf https://www.govinfo.gov/content/pkg/FR-2013-06-05/xml/FR-2013-06-05.xml fdlp 33689 33953 DGPO 2013-06-05 2024-06-03 FR-2013-06-05 machine generated eng FR FR-2013-06-05 78 108