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 2012_register executive 2012-12-22 article Notices D09002ee1c7fc09f2 D09002ee1c7fc0ac6 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) is announcing the availability for public comment of the Agency's draft environmental assessment (EA) of the proposed conditions of use specified in materials submitted by AquaBounty Technologies, Inc., in support of a new animal drug application (NADA) concerning a genetically engineered (GE) Atlantic salmon. Also available for comment is the Agency's preliminary finding of no significant impact (FONSI) for those specific conditions of use. 77 FR 76050 https://www.govinfo.gov/app/details/FR-2012-12-26/2012-31118 2012-31118 fr26de12-110 4160-01-P Docket No. FDA-2011-N-0899 https://www.govinfo.gov/app/details/FR-2012-12-26/2012-31118 https://www.govinfo.gov/content/pkg/FR-2012-12-26/html/2012-31118.htm https://www.govinfo.gov/content/pkg/FR-2012-12-26/pdf/2012-31118.pdf 1 p. 76050 76050 77 FR 76050 Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon; Availability; Federal Register Vol. 77, Issue NOTICE 2012-31118 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2013-02-25 Docket No. FDA-2011-N-0899 4160-01-P 2012-31118 Notice.

The Food and Drug Administration (FDA, the Agency) is announcing the availability for public comment of the Agency's draft environmental assessment (EA) of the proposed conditions of use specified in materials submitted by AquaBounty Technologies, Inc., in support of a new animal drug application (NADA) concerning a genetically engineered (GE) Atlantic salmon. Also available for comment is the Agency's preliminary finding of no significant impact (FONSI) for those specific conditions of use.

Submit either electronic or written comments on the Agency's draft EA and preliminary FONSI by February 25, 2013. Eric Silberhorn, Center for Veterinary Medicine (HFV-162), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8247, email:abig@fda.hhs.gov. Environmental Assessments; Availability, etc.: Genetically Engineered Atlantic Salmon , abig@fda.hhs.gov http://www.regulations.gov Vol. 77, no. 247 Office of the Federal Register, National Archives and Records Administration 2012-12-26 continuing daily deposited born digital 402 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-12-26 P0b002ee1839c2d36 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr26de12 https://www.govinfo.gov/app/details/FR-2012-12-26 https://www.govinfo.gov/content/pkg/FR-2012-12-26/pdf/FR-2012-12-26.pdf https://www.govinfo.gov/content/pkg/FR-2012-12-26/xml/FR-2012-12-26.xml fdlp 75823 76213 DGPO 2012-12-22 2024-06-03 FR-2012-12-26 machine generated eng FR FR-2012-12-26 77 247