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 2017_register executive 2017-10-28 article Notices D09002ee1c7f05dc1 D09002ee1c7f0600e 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Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Assessing User Fees Under the Generic Drug User Fee Amendments of 2017." This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application. 82 FR 50142 https://www.govinfo.gov/app/details/FR-2017-10-30/2017-23526 2017-23526 fr30oc17-50 4164-01-P Docket No. FDA-2012-D-0880 https://www.govinfo.gov/app/details/FR-2017-10-30/2017-23526 https://www.govinfo.gov/content/pkg/FR-2017-10-30/html/2017-23526.htm https://www.govinfo.gov/content/pkg/FR-2017-10-30/pdf/2017-23526.pdf 3 p. 50142 50144 82 FR 50142 Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability; Federal Register Vol. 82, Issue NOTICE 2017-23526 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-12-29 Docket No. FDA-2012-D-0880 4164-01-P 2017-23526 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Assessing User Fees Under the Generic Drug User Fee Amendments of 2017." This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application.

Submit either electronic or written comments on the guidance December 29, 2017 to ensure that the Agency considers your comment on this draft guidance. Mehrban Iranshad, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 4145, Silver Spring, MD 20993, 301-796-7900, CDERCollections@fda.hhs.gov. Guidance: Assessing User Fees under Generic Drug User Fee Amendments of 2017 , CDERCollections@fda.hhs.gov https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 82, no. 208 Office of the Federal Register, National Archives and Records Administration 2017-10-30 continuing daily deposited born digital 254 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-10-30 P0b002ee19746acb6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr30oc17 https://www.govinfo.gov/app/details/FR-2017-10-30 https://www.govinfo.gov/content/pkg/FR-2017-10-30/pdf/FR-2017-10-30.pdf https://www.govinfo.gov/content/pkg/FR-2017-10-30/xml/FR-2017-10-30.xml fdlp 50059 50304 DGPO 2017-10-28 2024-06-01 FR-2017-10-30 machine generated eng FR FR-2017-10-30 82 208