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 2022_register executive 2022-02-16 article Notices D09002ee1c7a8ab58 D09002ee1c7a8ac54 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, the Agency, or we) is announcing the following public workshop entitled "FY 2022 Generic Drug Science and Research Initiatives Workshop." The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholders--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its Fiscal Year (FY) 2023 Generic Drug User Fee Amendments (GDUFA) science and research initiatives. 87 FR 8843 https://www.govinfo.gov/app/details/FR-2022-02-16/2022-03368 2022-03368 fr16fe22-52 4164-01-P Docket No. FDA-2017-N-6644 https://www.govinfo.gov/app/details/FR-2022-02-16/2022-03368 https://www.govinfo.gov/content/pkg/FR-2022-02-16/html/2022-03368.htm https://www.govinfo.gov/content/pkg/FR-2022-02-16/pdf/2022-03368.pdf 3 p. 8843 8845 87 FR 8843 Fiscal Year 2022 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments; Federal Register Vol. 87, Issue NOTICE 2022-03368 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2022-06-10 Docket No. FDA-2017-N-6644 4164-01-P 2022-03368 Notice of public workshop; request for comments.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "FY 2022 Generic Drug Science and Research Initiatives Workshop." The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholders--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its Fiscal Year (FY) 2023 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.

The public workshop will be held on May 9, 2022, and May 10, 2022, from 8:30 a.m. to 4:30 p.m. Eastern Time. Submit either electronic or written comments on this public workshop by June 10, 2022. See the SUPPLEMENTARY INFORMATION section for registration date and information. Sam Raney, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4706, Silver Spring, MD 20993, 240-402-7967, Sameersingh.Raney@fda.hhs.gov; or Robert Lionberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402- 7957, Robert.Lionberger@fda.hhs.gov. Meetings: Fiscal Year 2022 Generic Drug Science and Research Initiatives Workshop, GDUFARegulatoryScience@fda.hhs.gov Robert.Lionberger@fda.hhs.gov Sameersingh.Raney@fda.hhs.gov https://fda.zoomgov.com/webinar/register/WN_kY1uqyD1RLqyRL2XU1KDTA https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf https://www.fda.gov/drugs/generic-drugs/science-research https://www.fda.gov/gdufaregscience https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 87, no. 32 Office of the Federal Register, National Archives and Records Administration 2022-02-16 continuing daily deposited born digital 220 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2022-02-16 P0b002ee1b3ddc400 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16fe22 https://www.govinfo.gov/app/details/FR-2022-02-16 https://www.govinfo.gov/content/pkg/FR-2022-02-16/pdf/FR-2022-02-16.pdf https://www.govinfo.gov/content/pkg/FR-2022-02-16/xml/FR-2022-02-16.xml fdlp 8733 8942 DGPO 2022-02-16 2024-05-29 FR-2022-02-16 machine generated eng FR FR-2022-02-16 87 32