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 2017-04-13 article Notices D09002ee1c7f1e9e7 D09002ee1c7f1ea78 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Government Agency or Subagency The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry (GFI) #187 entitled "Regulation of Intentionally Altered Genomic DNA in Animals" that was announced in the Federal Register of January 19, 2017. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. 82 FR 17844 https://www.govinfo.gov/app/details/FR-2017-04-13/2017-07470 2017-07470 fr13ap17-38 4164-01-P Docket No. FDA-2008-D-0394 https://www.govinfo.gov/app/details/FR-2017-04-13/2017-07470 https://www.govinfo.gov/content/pkg/FR-2017-04-13/html/2017-07470.htm https://www.govinfo.gov/content/pkg/FR-2017-04-13/pdf/2017-07470.pdf 2 p. 17844 17845 82 FR 17844 Regulation of Intentionally Altered Genomic DNA in Animals; Extension of Comment Period; Federal Register Vol. 82, Issue NOTICE 2017-07470 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-06-19 Docket No. FDA-2008-D-0394 4164-01-P 2017-07470 Notice of availability; extension of comment period.

The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry (GFI) #187 entitled "Regulation of Intentionally Altered Genomic DNA in Animals" that was announced in the Federal Register of January 19, 2017. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

We are extending the comment period on the draft guidance published January 19, 2017 (82 FR 6561). Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance, submit either electronic or written comments on the draft guidance by June 19, 2017. Laura R. Epstein, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-796-8558, laura.epstein@fda.hhs.gov. Guidance: Regulation of Intentionally Altered Genomic DNA in Animals , laura.epstein@fda.hhs.gov https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 82, no. 70 Office of the Federal Register, National Archives and Records Administration 2017-04-13 continuing daily deposited born digital 196 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-04-13 P0b002ee19488de28 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13ap17 https://www.govinfo.gov/app/details/FR-2017-04-13 https://www.govinfo.gov/content/pkg/FR-2017-04-13/pdf/FR-2017-04-13.pdf https://www.govinfo.gov/content/pkg/FR-2017-04-13/xml/FR-2017-04-13.xml fdlp 17745 17931 DGPO 2017-04-13 2024-06-01 FR-2017-04-13 machine generated eng FR FR-2017-04-13 82 70