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2016-01-16
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Request for Information on Development of a Performance Test Protocol for Closed System Transfer Devices That Incorporate Air-Cleaning Technology To Provide Worker Protection During Pharmacy Compounding and Administration of Hazardous Drugs
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Centers for Disease Control and Prevention
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United States Government Agency or Subagency
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) requests information for the development of a test protocol to evaluate the performance of closed system drug-transfer devices (CSTDs) that adopt air-cleaning technologies. CSTDs are generally available in two design types: (1) One that uses a physical barrier to block the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway and (2) one that uses air cleaning or filtration technologies to prevent the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway. A draft protocol titled, ``A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs,'' was developed by NIOSH to evaluate how protective the physical barrier-type CSTD devices were as an indicator of how effective they would be at preventing hazardous drug escape from the closed system. This RFI seeks information from the public regarding the feasibility of developing a protocol applicable to CSTDs using air cleaning or filtration technologies and to request information from stakeholders on this topic.
81 FR 2863
https://www.govinfo.gov/app/details/FR-2016-01-19/2016-00827
2016-00827
fr19ja16-61
4163-19-P
Docket Number CDC-2015-0075
NIOSH-288
https://www.govinfo.gov/app/details/FR-2016-01-19/2016-00827
https://www.govinfo.gov/content/pkg/FR-2016-01-19/html/2016-00827.htm
https://www.govinfo.gov/content/pkg/FR-2016-01-19/pdf/2016-00827.pdf
2 p.
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81 FR 2863
Request for Information on Development of a Performance Test Protocol for Closed System Transfer Devices That Incorporate Air-Cleaning Technology To Provide Worker Protection During Pharmacy Compounding and Administration of Hazardous Drugs; Federal Register Vol. 81, Issue
NOTICE
2016-00827
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
2016-03-08
Docket Number CDC-2015-0075
NIOSH-288
4163-19-P
2016-00827
Request for information and comment.
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) requests information for the development of a test protocol to evaluate the performance of closed system drug-transfer devices (CSTDs) that adopt air-cleaning technologies. CSTDs are generally available in two design types: (1) One that uses a physical barrier to block the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway and (2) one that uses air cleaning or filtration technologies to prevent the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway. A draft protocol titled, ``A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs,'' was developed by NIOSH to evaluate how protective the physical barrier-type CSTD devices were as an indicator of how effective they would be at preventing hazardous drug escape from the closed system. This RFI seeks information from the public regarding the feasibility of developing a protocol applicable to CSTDs using air cleaning or filtration technologies and to request information from stakeholders on this topic.
Electronic or written comments should be received on or before March 8, 2016.
Gayle DeBord, NIOSH, Division of Applied Research and Technologies, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-R2, Cincinnati, Ohio 45226, Phone: (513) 841-4256 [not a toll-free number], Email: hazardousdrugs@cdc.gov.
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Performance Test Protocol for Closed System Transfer Devices that Incorporate Air-Cleaning Technology to Provide Worker Protection During Pharmacy Compounding and Administration of Hazardous Drugs
,
hazardousdrugs@cdc.gov
http://www.regulations.gov
www.regulations.gov
Federal Register
Vol. 81, no. 11
Office of the Federal Register, National Archives and Records Administration
2016-01-19
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252 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2016-01-19
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0042-1219
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https://www.govinfo.gov/app/details/FR-2016-01-19
https://www.govinfo.gov/content/pkg/FR-2016-01-19/pdf/FR-2016-01-19.pdf
https://www.govinfo.gov/content/pkg/FR-2016-01-19/xml/FR-2016-01-19.xml
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