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 2006_register executive 2010-09-22 article Rules and Regulations D09002ee1c80f589c D09002ee1c80f593f 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) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. 71 FR 32827 https://www.govinfo.gov/app/details/FR-2006-06-07/E6-8790 E6-8790 fr07jn06-12 RIN 0910-AC25 4160-01-S Docket No. 2003N-0355 https://www.govinfo.gov/app/details/FR-2006-06-07/E6-8790 https://www.govinfo.gov/content/pkg/FR-2006-06-07/html/E6-8790.htm https://www.govinfo.gov/content/pkg/FR-2006-06-07/pdf/E6-8790.pdf Human Research Subjects Prisoners Reporting and Recordkeeping Requirements Safety 8 p. 32827 32834 71 FR 32827 Title 21 Part 50 21 CFR Part 50 RIN 0910-AC25 Medical Devices; Exception From General Requirements for Informed Consent; Federal Register Vol. 71, Issue RULE E6-8790 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2006-06-07 2006-08-07 Docket No. 2003N-0355 4160-01-S E6-8790 Interim final rule.

The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.

This rule is effective June 7, 2006. Submit written or electronic comments by August 7, 2006. Claudia M. Gaffey, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0496, ext. 109. Human Research Subjects Prisoners Reporting and Recordkeeping Requirements Safety Protection of human subjects: Ear, nose, and throat devices Medical devices; informed consent; general requirements exception, http://www.bt.cdc.gov/agent/agentlist-category.asp http://www.bt.cdc.gov/chemical/ http://www.fda.gov/dockets/ecomments http://www.hhs.gov/ohrp/policy/index.html Vol. 71, no. 109 Office of the Federal Register, National Archives and Records Administration 2006-06-07 continuing daily deposited born digital 353 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2006-06-07 P0b002ee180944de4 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07jn06 https://www.govinfo.gov/app/details/FR-2006-06-07 https://www.govinfo.gov/content/pkg/FR-2006-06-07/pdf/FR-2006-06-07.pdf https://www.govinfo.gov/content/pkg/FR-2006-06-07/xml/FR-2006-06-07.xml fdlp 32801 33145 DGPO 2010-09-22 2024-06-06 FR-2006-06-07 machine generated eng FR FR-2006-06-07 71 109