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 2017-10-14 article Notices D09002ee1c7f0db92 D09002ee1c7f0dc22 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Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Post- Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA." This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter). 82 FR 48093 https://www.govinfo.gov/app/details/FR-2017-10-16/2017-22288 2017-22288 fr16oc17-85 4164-01-P Docket No. FDA-2017-D-5928 https://www.govinfo.gov/app/details/FR-2017-10-16/2017-22288 https://www.govinfo.gov/content/pkg/FR-2017-10-16/html/2017-22288.htm https://www.govinfo.gov/content/pkg/FR-2017-10-16/pdf/2017-22288.pdf 3 p. 48093 48095 82 FR 48093 Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability; Federal Register Vol. 82, Issue NOTICE 2017-22288 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-12-15 Docket No. FDA-2017-D-5928 4164-01-P 2017-22288 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Post- Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA." This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter).

Submit either electronic or written comments on the draft guidance by December 15, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Tamara R. Coley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 75, Rm. 1668, Silver Spring, MD 20903, 240- 402-6903. Guidance: Post-Complete Response Letter Meetings Between Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Act , http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf 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. 198 Office of the Federal Register, National Archives and Records Administration 2017-10-16 continuing daily deposited born digital 249 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-10-16 P0b002ee1972acc53 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16oc17 https://www.govinfo.gov/app/details/FR-2017-10-16 https://www.govinfo.gov/content/pkg/FR-2017-10-16/pdf/FR-2017-10-16.pdf https://www.govinfo.gov/content/pkg/FR-2017-10-16/xml/FR-2017-10-16.xml fdlp 47953 48192 DGPO 2017-10-14 2024-06-01 FR-2017-10-16 machine generated eng FR FR-2017-10-16 82 198