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 2011-05-10 article Notices D09002ee1c7ffee13 D09002ee1c7ffeebf 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 or the Agency) is issuing this document to request comments relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications submitted under the Public Health Service Act (PHS Act). FDA is requesting input on the identified principles for development of a 351(k) user fee program, FDA's proposed structure for a 351(k) user fee program that would adhere to these principles, and performance goals for this program. FDA plans to review the comments submitted to the docket, hold meetings with public stakeholders, and hold industry stakeholder meetings to develop proposed recommendations for a user fee program for 351(k) applications for fiscal years (FYs) 2013 through 2017. 76 FR 27062 https://www.govinfo.gov/app/details/FR-2011-05-10/2011-11348 2011-11348 fr10my11-72 4160-01-P Docket No. FDA-2011-N-0326 https://www.govinfo.gov/app/details/FR-2011-05-10/2011-11348 https://www.govinfo.gov/content/pkg/FR-2011-05-10/html/2011-11348.htm https://www.govinfo.gov/content/pkg/FR-2011-05-10/pdf/2011-11348.pdf 6 p. 27062 27067 76 FR 27062 Biologics Price Competition and Innovation Act of 2009; Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Request for Comments; Federal Register Vol. 76, Issue NOTICE 2011-11348 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2011-06-09 2011-06-03 Docket No. FDA-2011-N-0326 4160-01-P 2011-11348 Notice; request for comments.

The Food and Drug Administration (FDA or the Agency) is issuing this document to request comments relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications submitted under the Public Health Service Act (PHS Act). FDA is requesting input on the identified principles for development of a 351(k) user fee program, FDA's proposed structure for a 351(k) user fee program that would adhere to these principles, and performance goals for this program. FDA plans to review the comments submitted to the docket, hold meetings with public stakeholders, and hold industry stakeholder meetings to develop proposed recommendations for a user fee program for 351(k) applications for fiscal years (FYs) 2013 through 2017.

Submit either electronic or written comments by June 9, 2011. Submit notification of interest in participating in public stakeholder meetings or industry stakeholder meetings on or before June 3, 2011. Sunanda Bahl, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993-0002, 301- 796-3584, FAX: 301-847-8443, e-mail: sunanda.bahl@fda.hhs.gov. Biologics Price Competition and Innovation Act of 2009: Options for User Fee Program for Biosimilar and Interchangeable Biological Product Applications, etc. , BiosimilarsUserFeeProgram@fda.hhs.gov sunanda.bahl@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/Drugs/GuidanceComplianceRegulatoryInformation/UCM215031 http://www.regulations.gov Vol. 76, no. 90 Office of the Federal Register, National Archives and Records Administration 2011-05-10 continuing daily deposited born digital 300 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2011-05-10 P0b002ee180cfa62f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10my11 https://www.govinfo.gov/app/details/FR-2011-05-10 https://www.govinfo.gov/content/pkg/FR-2011-05-10/pdf/FR-2011-05-10.pdf https://www.govinfo.gov/content/pkg/FR-2011-05-10/xml/FR-2011-05-10.xml fdlp 26927 27215 DGPO 2011-05-10 2024-06-04 FR-2011-05-10 machine generated eng FR FR-2011-05-10 76 90