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 2018_register executive 2018-06-29 article Proposed Rules D09002ee1c7e54682 D09002ee1c7e5484b 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 a public hearing to solicit comments on FDA's Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review, as applicable. 83 FR 30595 https://www.govinfo.gov/app/details/FR-2018-06-29/2018-14052 2018-14052 fr29jn18-25 4164-01-P Docket No. FDA-2018-N-2309 https://www.govinfo.gov/app/details/FR-2018-06-29/2018-14052 https://www.govinfo.gov/content/pkg/FR-2018-06-29/html/2018-14052.htm https://www.govinfo.gov/content/pkg/FR-2018-06-29/pdf/2018-14052.pdf 4 p. 30595 30598 83 FR 30595 Title 21 Part 15 21 CFR Part 15 The Food and Drug Administration Predictive Toxicology Roadmap and Its Implementation; Public Hearing; Request for Comments; Federal Register Vol. 83, Issue PRORULE 2018-14052 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2018-09-12 Docket No. FDA-2018-N-2309 4164-01-P 2018-14052 Notification of public hearing; request for comments.

The Food and Drug Administration (FDA or Agency) is announcing a public hearing to solicit comments on FDA's Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review, as applicable.

The public hearing will be held on Wednesday, September 12, 2018, from 9 a.m. to 4 p.m. Persons seeking to attend or to present at the public hearing must register by Wednesday, August 29, 2018. Section III provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until Friday, October 12, 2018. Tracy Chen, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4309A, Silver Spring, MD 20993, Tracy.Chen@fda.hhs.gov. Predictive Toxicology Roadmap and Its Implementation: Public Hearings , Jeffery.Rexrode@fda.hhs.gov shari.solomon@fda.hhs.gov Tracy.Chen@fda.hhs.gov https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm https://www.fda.gov/PredictiveToxRoadmap https://www.fda.gov/regulatoryinformation/dockets/default.htm https://www.regulations.gov Vol. 83, no. 126 Office of the Federal Register, National Archives and Records Administration 2018-06-29 continuing daily deposited born digital 315 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-06-29 P0b002ee19b3fa4ba 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr29jn18 https://www.govinfo.gov/app/details/FR-2018-06-29 https://www.govinfo.gov/content/pkg/FR-2018-06-29/pdf/FR-2018-06-29.pdf https://www.govinfo.gov/content/pkg/FR-2018-06-29/xml/FR-2018-06-29.xml fdlp 30525 30829 DGPO 2018-06-29 2024-06-01 FR-2018-06-29 machine generated eng FR FR-2018-06-29 83 126