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 2016-06-04 article Notices D09002ee1c7f61bde D09002ee1c7f61c62 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(FDA or Agency) is extending the comment period for the notice entitled "Labeling for Biosimilar Products; Draft Guidance for Industry; Availability" that appeared in the Federal Register of April 4, 2016. The Agency is taking this action to allow interested persons additional time to submit comments. 81 FR 36313 https://www.govinfo.gov/app/details/FR-2016-06-06/2016-13223 2016-13223 fr06jn16-81 4164-01-P Docket No. FDA-2016-D-0643 https://www.govinfo.gov/app/details/FR-2016-06-06/2016-13223 https://www.govinfo.gov/content/pkg/FR-2016-06-06/html/2016-13223.htm https://www.govinfo.gov/content/pkg/FR-2016-06-06/pdf/2016-13223.pdf 2 p. 36313 36314 81 FR 36313 Labeling for Biosimilar Products; Draft Guidance for Industry; Availability; Extension of Comment Period; Federal Register Vol. 81, Issue NOTICE 2016-13223 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-08-02 Docket No. FDA-2016-D-0643 4164-01-P 2016-13223 Notice of availability; extension of comment period.

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled "Labeling for Biosimilar Products; Draft Guidance for Industry; Availability" that appeared in the Federal Register of April 4, 2016. The Agency is taking this action to allow interested persons additional time to submit comments.

FDA is extending the comment period for the notice that published on April 4, 2016 (81 FR 19194) by an additional 60 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by August 2, 2016. Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1042; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Guidance: Labeling for Biosimilar Products; Extension of Comment Period , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 108 Office of the Federal Register, National Archives and Records Administration 2016-06-06 continuing daily deposited born digital 304 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-06-06 P0b002ee18fc78b8f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr06jn16 https://www.govinfo.gov/app/details/FR-2016-06-06 https://www.govinfo.gov/content/pkg/FR-2016-06-06/pdf/FR-2016-06-06.pdf https://www.govinfo.gov/content/pkg/FR-2016-06-06/xml/FR-2016-06-06.xml fdlp 36137 36431 DGPO 2016-06-04 2024-06-01 FR-2016-06-06 machine generated eng FR FR-2016-06-06 81 108