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 2021_register executive 2021-07-23 article Notices D09002ee1c7b04ed3 D09002ee1c7b04ff8 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), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting applications of patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum coordinated through the Office of Patient Affairs, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner, and is hosted by CTTI. Through the PEC, the patient community and regulators are able to discuss an array of topics regarding increasing meaningful patient engagement in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patients and patient advocates are partners in non-product specific aspects of the medical product development and FDA review process. 86 FR 39044 https://www.govinfo.gov/app/details/FR-2021-07-23/2021-15643 2021-15643 fr23jy21-89 4164-01-P Docket No. FDA-2017-N-6395 https://www.govinfo.gov/app/details/FR-2021-07-23/2021-15643 https://www.govinfo.gov/content/pkg/FR-2021-07-23/html/2021-15643.htm https://www.govinfo.gov/content/pkg/FR-2021-07-23/pdf/2021-15643.pdf 3 p. 39044 39046 86 FR 39044 Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative; Federal Register Vol. 86, Issue NOTICE 2021-15643 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2021-08-23 Docket No. FDA-2017-N-6395 4164-01-P 2021-15643 Notice; request for applications.

The Food and Drug Administration (FDA or Agency), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting applications of patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum coordinated through the Office of Patient Affairs, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner, and is hosted by CTTI. Through the PEC, the patient community and regulators are able to discuss an array of topics regarding increasing meaningful patient engagement in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patients and patient advocates are partners in non-product specific aspects of the medical product development and FDA review process.

Applications submitted by 11:59 p.m. Eastern time on August 23, 2021, will be considered for membership in the PEC. Incomplete applications and applications completed after the above-specified deadline will not be reviewed. Wendy Slavit, Office of the Commissioner, Office of Clinical Policy and Programs, Office of Patient Affairs, Food and Drug Administration, 301-796-8460, PatientEngagementCollaborative@fda.hhs.gov. Request for Applications: New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative, PatientEngagementCollaborative@fda.hhs.gov https://duke.qualtrics.com/jfe/form/SV_eLDSvmVIXdsAdVP https://www.ctti-clinicaltrials.org/framework-cttifda-patient-engagement-collaborative Vol. 86, no. 139 Office of the Federal Register, National Archives and Records Administration 2021-07-23 continuing daily deposited born digital 1042 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2021-07-23 P0b002ee1af4b150f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23jy21 https://www.govinfo.gov/app/details/FR-2021-07-23 https://www.govinfo.gov/content/pkg/FR-2021-07-23/pdf/FR-2021-07-23.pdf https://www.govinfo.gov/content/pkg/FR-2021-07-23/xml/FR-2021-07-23.xml fdlp 38905 39937 DGPO 2021-07-23 2024-05-30 FR-2021-07-23 machine generated eng FR FR-2021-07-23 86 139