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 2016_register executive 2018-02-14 article Notices D09002ee1c7f32f10 D09002ee1c7f32fa6 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 Agency) is announcing the availability of guidance for industry entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments." This guidance provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes the revised version of the guidance. 81 FR 81774 https://www.govinfo.gov/app/details/FR-2016-11-18/2016-27761 2016-27761 fr18no16-83 4164-01-P Docket No. FDA-2012-D-0880 https://www.govinfo.gov/app/details/FR-2016-11-18/2016-27761 https://www.govinfo.gov/content/pkg/FR-2016-11-18/html/2016-27761.htm https://www.govinfo.gov/content/pkg/FR-2016-11-18/pdf/2016-27761.pdf 3 p. 81774 81776 81 FR 81774 Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability; Federal Register Vol. 81, Issue NOTICE 2016-27761 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-D-0880 4164-01-P 2016-27761 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments." This guidance provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes the revised version of the guidance.

Submit either electronic or written comments on Agency guidances at any time. Mehrban Iranshad, Division of User Fee Management and Budget Formulation staff, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 4145, Silver Spring, MD 20993, 301-796-7900, AskGDUFA@fda.hhs.gov. Guidance for Industry: Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments , AskGDUFA@fda.hhs.gov http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 223 Office of the Federal Register, National Archives and Records Administration 2016-11-18 continuing daily deposited born digital 1471 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-11-18 P0b002ee1986804d6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr18no16 https://www.govinfo.gov/app/details/FR-2016-11-18 https://www.govinfo.gov/content/pkg/FR-2016-11-18/pdf/FR-2016-11-18.pdf https://www.govinfo.gov/content/pkg/FR-2016-11-18/xml/FR-2016-11-18.xml fdlp 81641 83105 DGPO 2018-02-14 2024-06-01 FR-2016-11-18 machine generated eng FR FR-2016-11-18 81 223