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 2011_register executive 2011-12-07 article Notices D09002ee1c7fea640 D09002ee1c7fea6c2 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 to discuss the proposed recommendations for a user fee program for biosimilar biological products for fiscal years (FYs) 2013 through 2017. 76 FR 76424 https://www.govinfo.gov/app/details/FR-2011-12-07/2011-31499 2011-31499 fr07de11-83 4160-01-P Docket No. FDA-2011-N-0326 https://www.govinfo.gov/app/details/FR-2011-12-07/2011-31499 https://www.govinfo.gov/content/pkg/FR-2011-12-07/html/2011-31499.htm https://www.govinfo.gov/content/pkg/FR-2011-12-07/pdf/2011-31499.pdf 6 p. 76424 76429 76 FR 76424 Biologics Price Competition and Innovation Act of 2009; Proposed Recommendations for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Notice of Public Meeting; Request for Comments; Federal Register Vol. 76, Issue NOTICE 2011-31499 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2012-01-06 2011-12-16 Docket No. FDA-2011-N-0326 4160-01-P 2011-31499 Notice of public meeting; request for comments.

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed recommendations for a user fee program for biosimilar biological products for fiscal years (FYs) 2013 through 2017.

The public meeting will be held on Friday, December 16, 2011, from 9 a.m. to 1 p.m. Registration to attend the meeting must be received by December 14, 2011. See section III.B of this document for information on how to register for the meeting. Submit either electronic or written comments by January 6, 2012. Rokhsana Safaai-Jazi, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 1164, Silver Spring, MD 20993-0002, (301) 796-4463, Fax: (301) 847-8443, Email: BiosimilarsUserFeeProgram@fda.hhs.gov. Recommendations for User Fee Programs: Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Meeting , BiosimilarsUserFeeProgram@fda.hhs.gov http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf http://edocket.access.gpo.gov/2010/pdf/2010-30713.pdf http://www.fda.gov http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/UCM215031 http://www.fda.gov/ForIndustry/UserFees/ucm268124.htm http://www.gpo.gov/fdsys/pkg/FR-2011-05-10/pdf/2011-11348.pdf http://www.regulations.gov Vol. 76, no. 235 Office of the Federal Register, National Archives and Records Administration 2011-12-07 continuing daily deposited born digital 316 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2011-12-07 P0b002ee181247d08 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07de11 https://www.govinfo.gov/app/details/FR-2011-12-07 https://www.govinfo.gov/content/pkg/FR-2011-12-07/pdf/FR-2011-12-07.pdf https://www.govinfo.gov/content/pkg/FR-2011-12-07/xml/FR-2011-12-07.xml fdlp 76293 76600 DGPO 2011-12-07 2024-06-03 FR-2011-12-07 machine generated eng FR FR-2011-12-07 76 235