Document Yr4oOGxjJE0EV6YxGvwN923NO
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Hebert, John [/0=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=07F9BBCF7C7C4219AA78A9618F7EAD54-JOHN D. HEBERT] 11/16/2017 8:37:18 PM Green, Joseph J. [JGreen@KelleyDrye.com] Knizner, Steve [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=3920dal4a514463bb691dl6bf903ef33-Steve Knizner]; Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy]; Weiss, Steven [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=6ce04987a3784f21985f65e96c220b84-Weiss, Steven] RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi Joe - Sorry for the delay. The charge questions are going through the last phase of internal review. I hope to have a copy for CDA's review very shortly.
Thanks, John
John Hebert, Chief Registration Management Branch I Antimicrobials Division Office of Pesticide Programs Environmental Protection Agency (703) 308-6249 hebert.john@epa.gov
From: Green, Joseph J. [mailto:JGreen@KelleyDrye.com] Sent: Thursday, November 16, 2017 2:56 PM To: Hebert, John <Hebert.John@epa.gov> Cc: Knizner, Steve <Knizner.Steve@epa.gov>; Beck, Nancy <Beck.Nancy@epa.gov>; Weiss, Steven <Weiss.Steven@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi John -
Just checking in on progress with the panei and charge questions.
Thanks Joe
JOSEPH J, GREEN Spedai Counsel Mi:tL.Dti.&.W arren LLP
Ex. 6
jGreen@KelleyDrye.com
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From: Hebert, John [mailto:Hebert.John@epa.gov1 Sent: Thursday, October 26, 2017 9:06 AM To: Green, Joseph J. <JGreen@KelleyDrye.com> Cc: Knizner, Steve <Knizner.Steve@epa.gov>; Beck, Nancy <Beck.Nancy@epa.gov>; Weiss, Steven <Weiss.Steven@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi Joe - The charge questions are currently undergoing internal review. We'll definitely provide the questions for CDA's review/comment before they are finalized. As for timing, it will probably be no earlier than the week of November 6.
Regards, John
From: Green, Joseph J. [mailto:JGreen@KellevDrye.com1 Sent: Wednesday, October 25, 2017 4:53 PM To: Hebert, John <HebertJohn@epa.gov> Cc: Knizner, Steve <Knizner.Steve@epa.gov>; Beck, Nancy <Beck.Nancv@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi John - Checking in again to see about a chance to review the draft charge questions, as noted below. Thanks Joe
From: Green, Joseph J. Sent: Friday, October 13, 2017 11:06 AM To: 'Hebert, John1<HebertJohn@epa.gov> Cc: Knizner, Steve <Knizner.Steve@epa.gov>; Beck, Nancy <Beck.Nancy@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
John - Thanks for the response. We appreciate the agency's efforts to keep this moving. As discussed during our call in June, CDA would like to review the charge questions to ensure that they properly frame the Issues that we think will be paramount as we look towards future registration of claims. Let me know when we might be able to see a draft.
Thanks again and have a great weekend. Joe
JOSEPH J, GREEN
Specs! Counsel Kelley Drye *> Warren LLP
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jGreen@KelieyDrye.com
From: Hebert, John [mailto:Hebert.John@epa.gov1 Sent: Thursday, October 12, 2017 6:20 PM To: Green, Joseph J. <JGreen@KelleyDrye.com> Cc: Knizner, Steve <Knizner.Steve@epa.gov>; Beck, Nancy <Beck.Nancy@epa.gov>
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Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hello Joe - I apologize for not getting back to you earlier. The current status is that we are close to finalizing the letter that we will share with our federal partners that will include a request for a reviewer, the charge questions and the criteria for the review. I ensure you that we are still focused on this issue and I will let you know as soon as I have any updates on our progress.
Thanks, John
John Hebert, Chief Registration Management Branch I Antimicrobials Division Office of Pesticide Programs Environmental Protection Agency (703) 308-6249 hebert.iohn@epa.gov
From: Green, Joseph J. imailto:JGreen@KellevDrve.com1 Sent: Wednesday, October 11, 2017 10:20 AM To: Hebert, John <HebertJohn@epa.gov> Cc: Knizner, Steve <Knizner.Steve@epa.gov>; Beck, Nancy <Beck.Nancv@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi John and all -
From our discussions in June, CDA was encouraged that a panel to review the clinical trial studies would be formed promptly and in an open and cooperative manner. CDA provided the data to ERA on August 8, and recommendations on potential panel members for consideration on September 12. We understand that the agency is seeking appropriate reviewers, but it is unclear what kind of progress has been made in terms of panel formation or other aspects of the review process, such as developing draft panel questions. It is vital that we maintain momentum and focus on the issue.
Please let us know where things stand and the schedule for moving forward. CDA also is happy to initiate drafting of questions for the panel, or to discuss development of the questions with ERA.
Thanks and best regards, Joe
JOSEPH J. GREER
Special Counsel Kelley Drye A Warren LLP
lI I S lI I j
jGreen@KelleyDrye.com Counsel to the Copper Development Association
From: Green, Joseph J. Sent: Wednesday, October 04, 2017 12:36 PM
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To: 'Hebert, John' <HebertJohn@epa.gov> Cc: Knizner, Steve <Knizner.Steve@epa.gov>; Beck, Nancy <Beck.Nancv@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi John - Any further update on the review panel? Thanks Joe
JOSEPH J. GREEN
Specs! Counsel Kelley Drye A Warren LLP
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JGreen@KeiteyDrye.com
From: Hebert, John [mailto:Hebert.John@epa.gov1 Sent: Wednesday, September 13, 2017 5:43 PM To: Green, Joseph J. <JGreen@KelleyDrye.com> Cc: Knizner, Steve <Knizner.Steve@epa.gov>; Beck, Nancy <Beck.Nancv@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hello Joe - Thank you for CDA's list of potential candidates. We will take your recommendations in consideration as we continue to work on finding appropriate agencies and institutions to review the clinical study. We'll be in touch when we have more information to share with you on this.
Thanks, John
John Hebert, Chief Registration Management Branch I Antimicrobials Division Office of Pesticide Programs Environmental Protection Agency (703) 308-6249 hebert.iohn@epa.gov
From: Green, Joseph J. [mailto:JGreen@KellevDrye.com1 Sent: Tuesday, September 12, 2017 12:53 PM To: Hebert, John <HebertJohn@epa.gov> Cc: Knizner, Steve <Knizner.Steve@epa.gov>; Beck, Nancy <Beck.Nancy@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi John -
Following up on my message last week, attached please find a list of potential candidates for potential Inclusion on the review panel. GDA attempted to identify candidates with relevant expertise in the field that have not previously been involved or associated with the clinical trials.
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We look forward to working with EPA on the panel selection process and in developing the charge questions. Thanks again for your continued attention to this matter.
Regards, Joe
JOSEPH J. CREEP
Special Counsel Kelley Drye & Warren LLP
JGreen@KelieyDrye.com
From: Green, Joseph J. Sent: Tuesday, September 05, 2017 4:45 PM To: 'Hebert, John' <HebertJohn@epa.gov> Cc: Knizner, Steve <Knizner.Steve@epa.gov>; Beck, Nancy <Beck.Nancv@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi John -
Thanks for the response and the information on the status of the panel selection process. During our June cali, EPA offered to consult with CDA regarding selection of the panel members and we would like to do so. in particular, given CDA's detailed knowledge of the clinical trials, we think it would be helpful to review and provide feedback on the draft panel questions, as well as in Identifying potential panel members. CDA is developing a list of potential reviewers who have not previously been involved or otherwise associated with the trials but have expertise and standing that would be relevant to potential participation in the panel. We wili send that list to you in short order for consideration.
After we have a chance to consider the pane! review questions, perhaps a foliow up conference cali with EPA would make sense at that point
Thanks again for your continued attention to this matter.
Regards, Joe
jGreen@KelieyDrye.com
From: Hebert, John [mailto:Hebert.John@epa.gov1 Sent: Tuesday, September 05, 2017 11:40 AM To: Green, Joseph J. <JGreen@KelleyDrye.com> Cc: Knizner, Steve <Knizner.Steve@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hello Joe - The update on where we are since our last meeting is that the Antimicrobials Division has assembled a task group that meets weekly to work on the review process for the clinical study. This group is in the process of drafting questions and criteria for review of the clinical study. The group is also working to identify appropriate
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agencies/institutions to review the study, and specific qualifications needed for reviewers. We have engaged with the EPA Office of the Science Advisor to facilitate outreach to reviewers and are coordinating with the Human Research Ethics and Oversight staff.
This is where we currently are so if we have a call, I don't think we'll have anything more substantive to add. But let me know if you would still like a call or if you have any questions.
Regards, John
John Hebert, Chief Registration Management Branch I Antimicrobials Division Office of Pesticide Programs Environmental Protection Agency (703) 308-6249 hebert.john(5)epa.gov
From: Green, Joseph J. [mailto:JGreen(SKellevDrye.com1 Sent: Wednesday, August 30, 2017 4:27 PM To: Hebert, John <Hebert.John@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi John -
I believe you are out of the office for the remainder of the week, but wanted to touch base to set up a call with CDA/EPA regarding the panei seiection process, (per our letter with the data submission, excerpted below) Let me know what you think on possibie dates for such a call.
Thanks Joe
JOSEPH J. GREEN
Special Counsel KMte.Ooce.i.Werreo LLP
Ex. 6
JGreen@KelieyDrye.com
Finally, as discussed on our call, CDA looks forward to assisting EPA in the review panel selection process. Currently, we are working on identifying experts for EPA's consideration. To ensure continued progress, we believe it would be helpful to have a call to discuss the panel selection process and schedule, including, as noted on our call and follow-up letter of June 26th, areas of expertise and other criteria to ensure that a conflict of interest does not exist for any of the reviewers. Please let us know your availability for such a call.
From: Green, Joseph J. Sent: Sunday, August 20, 2017 1:12 PM To: Hebert, John <HebertJohn@epa.gov> Cc: Murasaki, Seiichi <Murasaki.Seiichi@epa.gov>
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Subject: Re: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Thanks John. We are good with the approach to the data submission as you described below - you have our OK to proceed.
One note: the spreadsheets are rather large and it may be tricky to get it all on a normal size PDF. Just want to make sure the data doesn't get truncated when put in that format.
Thanks again - and hope you are heading off on a good vacation!
Joe
On Aug 19, 2017, at 8:59 PM, Hebert, John <Hebert.John@epa.gov> wrote:
Hi Joe - I just wanted to let you know that I will be out of the office until August 30. Seiichi Murasaki can help you with this while I'm out of the office.
Thanks, John
From: Hebert, John Sent: Friday, August 18, 2017 10:57 AM To: 'Green, Joseph J.' <JGreen@KellevDrye.com> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi Joe - I talked to the front end about this. We can take the electronic files you submitted and turn them into PDFs and assign that an MRID. We cannot assign MRIDs to electronic files and the data cannot be appended the clinical study (that's why it needs a new MRID). The supporting documents that were in your email will also be included. The data will be linked to the clinical study in our system and by name. For example, something like, "Data for the Clinical Trial of the.... (MRID 49108501). " The entire new MRID will be considered confidential. It's my impression that you don't have to do anything. The front end can work with the documents in the email. Since nothing is formatted per PRN 2011-3, the submission will technically get a failure for compliance to that. But we will just ignore that. There is really nothing for you to do other than give me your "ok" to go ahead. Sorry, if this seems complicated but I do think it's important for the data to be part of the official record and to link it with the clinical study.
Please let me know if you have any questions.
Thanks, John
From: Green, Joseph J. [mailto:JGreen@KellevDrye.com1 Sent: Tuesday, August 15, 2017 6:40 PM To: Hebert, John <Hebert.John@epa.gov> Subject: Re: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Thanks John
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On Aug 15, 2017, at 6:03 PM, Hebert, John <Hebert.John@epa.gov> wrote:
Joe - Let me check on this and I'll get back to you.
John
From: Green, Joseph J. [mailto:JGreen@KelleyDrye.coml Sent: Monday, August 14, 2017 1:13 PM To: Hebert, John <HebertJohn@epa.gov>; Beck, Nancy <Beck.Nancy(5)epa.gov> Cc: Hilbert, John <ihilbert(gkhaconsultants.com>; 'Thomas Passek' <thomas.passek@copperalliance.us>; adam.estelle@copperalliance.us; andrew.kiretajr@copperalliance.us; Knizner, Steve <Knizner.Steve@epa.gov>; Jakob, Avivah <Jakob.Avivah@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi John -
Thanks for your message on Friday.
CBI / Ex. 4
CBI / Ex. 4
CBI / Ex" 4
For that reason,
the spreadsheets are electronic and password-protected. Is there a way to
submit such electronic files through the front end?
Thanks
JOSEPH J, GREEH
Specs! Counsel Kelley Drye & Warren LLP
p ZZIZa ZZZ
JOre e n fp O lle y D ry e .com
From: Hebert, John [mailto:Hebert.John@epa.gov1 Sent: Friday, August 11, 2017 2:00 PM To: Green, Joseph J. <JGreen@KellevDrye.com>; Beck, Nancy <Beck.Nancy@epa.gov> Cc: Hilbert, John <ihilbert@khaconsultants.com>; 'Thomas Passek' <thomas.passek@copperalliance.us>; adam.estelle@copperalliance.us; andrew.kiretajr@copperalliance.us; Knizner, Steve <Knizner.Steve@epa.gov>; Jakob, Avivah <Jakob.Avivah@epa.gov> Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
Hi Joe - Thank you for your email. I just wanted to confirm that you are also submitting the files officially through the front end. We would like the Clinical Trial (MRID
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49108501; submitted April 24, 2013) to be amended to include these data. Please let me know if you have any questions.
Regards, John
John Hebert, Chief Registration Management Branch I Antimicrobials Division Office of Pesticide Programs Environmental Protection Agency (703) 308-6249 hebert.iohn@epa.gov
From: Green, Joseph J. [mailto:JGreen@KellevDrye.com1 Sent: Tuesday, August 08, 2017 11:29 AM To: Beck, Nancy <Beck.Nancy@epa.gov> Cc: Hebert, John <HebertJohn@epa.gov>; Hilbert, John <ihilbert@khaconsultants.com>; 'Thomas Passek1<thomas.passek@copperalliance.us>; adam.estelle@copperalliance.us; andrew.kiretajr@copperalliance.us Subject: RE: Copper Development Association: Review and Approval of Claims for Antimicrobial Copper Products Based on Clinical Trial Results (Confidential Business Information)
** Confidential Business Information **
Dear Deputy Assistant Administrator Beck -
.------------------------------ j
The Copper Development Association (CDA) is pleased to submit to ERA j CBI7Ex-4i
..........CBI./Ex. 4......
and how 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
;i ; J
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Kelley Dry & Warren LLP
jGreen@KeyeyDrye.com
From: Beck, Nancy [mailto:Beck.Nancv@epa.gov1 Sent: Monday, June 26, 2017 5:01 PM To: Green, Joseph J. <JGreen@KellevDrye.com> Cc: Kaiser, Sven-Erik <Kaiser.Sven-Erik@epa.gov>; Hebert, John <Hebert.John@epa.gov>; Hilbert, John <hilbert@khaconsultants.com>; 'Thomas Passek1<thomas.passek@copperalliance.us>; adam.estelle@copperalliance.us 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 P: 202-564-1273 M :i Ex. 6 Personal Privacy (PP) i
i________________________ j
bec.k.nancy@epa.gov
From: Green, Joseph J. [mailto:JGreen@KellevDrye.com1 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
JOSEPH J. GREEN
Special Counsel Kelley Drye & Warren LLP Washington Harbour 3050 K Street NWf Suite 400 Washington, DC 20007
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Tel:
Ex. 6
JGrenlKlyDrTcom"'"'"'
Counsel to the Copper Development Association
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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 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.
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