Document ID: EPA-HQ-ORD-2015-0588-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-12-14T05:00Z

US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                    October 19, 2015 PUBLIC MEETING AGENDA
                                       
                           Internet Virtual Meeting
            The meeting will be conducted at the following website:
                     https://epa.connectsolutions.com/hsrb
                                       
           And on the phone: 866-299-3188 (access code: 2025647189)
                                       
                           Monday, October 19, 2015

                  HSRB WEB SITE http://www.epa.gov/osa/hsrb/
                       Docket Telephone: (202) 566 1752
                  Docket Number: EPA - HQ - ORD - 2015 - 0588
                                       
12:50 PM	HSRB members login online

1:00 PM*	Convene Public Meeting  -  Jim Downing, Designated Federal Officer, EPA Human Studies Review Board, Office of the Science Advisor
	Virtual Meeting operations  -  Liza Dawson, Ph.D., HSRB Chair
           Introduction of Board Members  -  Liza Dawson, Ph.D., HSRB Chair
           Opening Remarks  -  Thomas Sinks, Ph.D., Director, Office of the Science Advisor, EPA
	
Completed Study from the U.S. Department of Agriculture Describing Laboratory Evaluation of Bite Protection from Repellent-Impregnated Clothing for the United States Military 

1:20 PM 	EPA Science Review Highlights  -  Mr. Kevin Sweeney (Registration Division, OPP, EPA)
1:40 PM 	Board Questions of Clarification  -  Liza Dawson, Ph.D., HSRB Chair, EPA staff
2:05 PM	EPA Ethics Review Highlights - Maureen Lydon (OPP, EPA)
2:25 PM	Board Questions of Clarification  -  Liza Dawson, Ph.D., HSRB Chair, EPA staff
2:50 PM 	Public Comments 
2:55 PM	Board Discussion

Charge to the Board - Science:

* Is the research reported in the completed study sufficiently sound, from a scientific perspective, to be used to evaluate the bite protection level of etofenprox-treated military clothing? 

Discussants: Randy Maddalena, Ph.D. (Ed Gbur, statistics)

Charge to the Board - Ethics:

* Does available information support a determination that the research was conducted in substantial compliance with 40 CFR part 26, subparts K and L?

Discussant: Gary L. Chadwick, Pharm.D., M.P.H, C.I.P.

5:00 PM* 	Adjourn	

                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                    October 20, 2015 PUBLIC MEETING AGENDA
                                       
                           Internet Virtual Meeting
            The meeting will be conducted at the following website:
                     https://epa.connectsolutions.com/hsrb
                                       
           And on the phone: 866-299-3188 (access code: 2025647189)
                                       
                           Tuesday, October 20, 2015

                  HSRB WEB SITE http://www.epa.gov/osa/hsrb/
                       Docket Telephone: (202) 566 1752
                  Docket Number: EPA - HQ - ORD - 2015 - 0588
                                       
12:50 PM	HSRB members login online

1:00 PM*	Convene Public Meeting  -  Jim Downing, Designated Federal Officer, EPA Human Studies Review Board, Office of the Science Advisor
	Virtual Meeting operations  -  Liza Dawson, Ph.D., HSRB Chair
            Introduction of Board Members  -  Liza Dawson, Ph.D., HSRB Chair
	Opening Remarks  -  Toby Schonfeld, Ph.D., Human Subjects Research Review Official, Office of the Science Advisor, EPA
	
Protocol for Testing of S.C. Johnson Personal Tick Repellent Products to Support Use of EPA Repellency Awareness Graphic

1:15 PM 	EPA Science Review Highlights  -  Mr. Kevin Sweeney, and Eric Bohnenblust, Ph.D. (Registration Division, OPP, EPA)
1:35 PM 	Board Questions of Clarification  -  Liza Dawson, Ph.D., HSRB Chair, EPA staff
2:00 PM	EPA Ethics Review Highlights - Maureen Lydon (OPP, EPA)
2:40 PM	Board Questions of Clarification  -  Liza Dawson, Ph.D., HSRB Chair, EPA staff
3:10 PM 	Public Comments 
3:15 PM	Board Discussion

Charge to the Board - Science:

If the S.C. Johnson & Son, Inc. and i2LResearch protocol is revised as suggested in EPA's review and if the research is performed as described: 

   * Is the protocol "Testing of S.C. Johnson Personal Tick Repellent Products to Support their Use of the EPA Repellency Awareness Graphic" likely to generate scientifically reliable data, useful for estimating the complete protection time of various EPA-registered S.C. Johnson skin-applied tick repellents in the laboratory against three species of ticks? 

Discussants: Kenneth Ramos, Ph.D. (Jun Zhu, Ph.D., statistics)

Charge to the Board - Ethics:

   * Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L? 

Discussant: Kyle Galbraith, Ph.D.

5:00 PM* 	Adjourn