Document wv0jR4K7yj867zkX5DYd2L33

Message From: Sent: To: CC: Subject: Attachments: Green, Joseph J. [JGreen@KelleyDrye.com] 8/8/2017 3:29:11 PM Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy] Hebert, John [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=07f9bbcf7c7c4219aa78a9618f7ead54-John D. Hebert]; Hilbert, John [jhilbert@khaconsultants.com]; 'Thomas Passek1[thomas.passek@copperalliance.us]; adam.estelle@copperalliance.us; andrew.kiretajr@copperalliance.us RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information) Antimicrobial Copper Alloys - Submission of Clinical Trial Data Cover le_pdf; Copper_Clinical_Trial_Outcome_Data.xlsx; Copper_Clinical_Trial_Burden_Data.xlsx; Copper_Clinical_Trial_Data_Files_Review_Guidance.docx; Antimicrobial Copper Alloys - Amendment to Add Clinical Trial Claims - C....doc; Volume 2 of 2_Clinical Trial-Copper and HAI Claims with refs.pdf; JCM_2012_Schmidt_CuBurden.pdf; ICHE_2013_Schmidt_CuContinuously.pdf; ICHE_2013_Salgado_Culnfections.pdf; Antimicrobial Copper Alloys - Label Claims Based on Clinical Trial Resul....docx; ICHE_Reply_to_Harbarth_2013.pdf Flag: Flag for follow up ** Confidential Business Information ** Dear Deputy Assistant Administrator Beck - The Copper Development Association (CDA) CBI / Ex. 4 CBI / Ex. 4 to access them, as well as the supporting documents. As noted in the letter, please treat the data files and accompanying information as Confidential Business Information and limit distribution and access accordingly. We also request a call to follow up on the review panel selection criteria and process. Please let us know the availability of you and your team for such a call. Your continued attention to this matter is greatly appreciated. If you have any questions about the data files or other attachments, please do not hesitate to contact me. Regards, Joe JOSEPH J. GREEN Special Counsel Kelley Drye & Warren LLP ----- | lGreen#KeneyD'fye7com From: Beck, Nancy [mailto:Beck.Nancy@epa.gov] Sent: Monday, June 26, 2017 5:01 PM To: Green, Joseph J. <JGreen@KelleyDrye.com> Cc: Kaiser, Sven-Erik <Kaiser.Sven-Erik@epa.gov>; Hebert, John <Hebert.John@epa.gov>; Hilbert, John <jhilbert@khaconsultants.com>; 'Thomas Passek' <thomas.passek@copperalliance.us>; adam.estelle@copperalliance.us Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00042502-00001 Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results Thank you Joe. We look forward to working with CDA to make some progress in this space. John Hebert will be our main point of contact. Regards, Nancy Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP PM: ______E__x__.__6_______! beck.nancy@epa.gov From: Green, Joseph J. imailto:JGreen@KellevDrve.coml Sent: Monday, June 26, 2017 1:47 PM To: Beck, Nancy <Beck.Nancy@epa.gov> Cc: Kaiser, Sven-Erik <Kaiser.Sven-Erik@epa.gov>; Hebert, John <HebertJohn@epa.gov>; Hilbert, John <ihilbert@khaconsultants.com>; 'Thomas Passek' <thomas.passek@copperalliance.us>; adam.estelle@copperalliance.us Subject: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results Dear Deputy Assistant Administrator Beck - Please see the attached letter following up on our call last Friday. Regards, Joe The information contained in this E-mail message is privileged, confidential, and may be protected from disclosure; please be aware that any other use, printing, copying, disclosure or dissemination of this communication may be subject to legal restriction or sanction. If you think that you have received this E-mail message in error, please reply to the sender. This E-mail message and any attachments have been scanned for viruses and are believed to be free of any virus or other defect that might affect any computer system into which it is received and opened. However, it is the Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00042502-00002 responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Kelley Drye & Warren LLP for any loss or damage arising in any way from its use. The information contained in this E-mail message is privileged, confidential, and may be protected from disclosure; please be aware that any other use, printing, copying, disclosure or dissemination of this communication may be subject to legal restriction or sanction. If you think that you have received this E-mail message in error, please reply to the sender. This E-mail message and any attachments have been scanned for viruses and are believed to be free of any virus or other defect that might affect any computer system into which it is received and opened. Elowever, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Kelley Drye & Warren LLP for any loss or damage arising in any way from its use. Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00042502-00003