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Green, Joseph J. [JGreen@KelleyDrye.com] 1/5/2018 3:01:43 PM Hebert, John [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=07f9bbcf7c7c4219aa78a9618f7ead54-John D. Hebert] Weiss, Steven [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=6ce04987a3784f21985f65e96c220b84-Weiss, Steven]; Keigwin, Richard [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=151baabb6a2246a3a312fl2a706c0a05-Richard P Keigwin Jr]; Hughes, Hayley [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=d98153a3667544ce81b60dd0blecbd0d-Hughes, Hay]; Willis, Kristen [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=0b437bee32204a51aed37522b09153f3-Willis, Kri]; Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy] RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review EPA_Draft_Charge_Questions_for__Copper__Clinical_Study__CDA_edits_04Jan2018 vl.docx; Antimicrobial Copper Alloys - Clinical Trial Claim Expert Review Panel Charge Questions and Schedule vl.docx; Antimicrobial Copper Alloys Group 1 - Registered Label (2014).pdf
Hi John -
Thanks again for sending the draft charge questions, in the attached letter and red-line document, CDA has a few suggestions on the questions and some recommendations for moving forward, inciuding a suggested timeline to help maintain progress in getting the review of the copper clinical trial underway and completed. We do hope that the process can get started in the next week or so (by January 15) with sending out the initial communication from ERA to prospective panel members, as noted in our letter. To that end, I will be forwarding a suggested cover letter in the next day or so.
Please let us know if you have any questions or need any additional information, and keep us posted on how things proceed.
Also, best wishes with the new posting. We have appreciated working with you and look forward to continuing to do so.
Regards, Joe
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00038598-00001
From: Hebert, John [mailto:Hebert.John@epa.gov] Sent: Friday, December 15, 2017 3:52 PM To: Green, Joseph J. <JGreen@KelleyDrye.com> Cc: Weiss, Steven <Weiss.Steven@epa.gov>; Keigwin, Richard <Keigwin.Richard@epa.gov>; Hughes, Hayley <hughes.hayley@epa.gov>; Willis, Kristen <Willis.Kristen@epa.gov> Subject: Draft Charge Questions
Hello Joe - Please see the attached draft charge questions. Along with charge questions, we intend to provide our federal partners with a white paper that describes the general registration process including efficacy data requirements for products making public health claims. 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 heberf.john@epa.gov
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Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00038598-00002