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Green, Joseph J. [JGreen@KelleyDrye.com] 1/8/2018 7:00:53 PM Hebert, John [/o=ExchangeLabs/ou=Exchange Adm inistrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=07f9bbcf7c7c4219aa78a9618f7ead54-John D. Hebert] Weiss, Steven [/o=ExchangeLabs/ou=Exchange Adm inistrative 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 Proposed EPA Cover Letter to Clinical Trial Expert Panel Reviewers vl.docx
Hi all - Following up on last week's message and forwarding a proposed draft cover letter for sending the charge questions and other materiais to prospective panel reviewers. Please let us know if you have any questions or if you would like to discuss.
CDA appreciates your continued efforts in moving forward with review and consideration of the copper clinical trial data and associated claims.
Regards, Joe
JOSEPH J. CREEP Special Counsel Kelley Drye & Warren LLP (202) 3420849 3Green@KelleyDrye.com Counsel to the Copper Development Association
From: Green, Joseph J. Sent: Friday, January 05, 2018 10:02 AM To: 'Hebert, John1<Hebert.John@epa.gov> 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>; 'beck.nancy@epa.gov' <beck.nancy@epa.gov> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review
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, including 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 EPA to prospective panel members, as noted in our letter. To that end, I wil be forwarding a suggested cover letter in the next day or so.
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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
From: Hebert, John [mailto:Hebert.John@epa.gov1 Sent: Friday, December 15, 2017 3:52 PM To: Green, Joseph J. <JGreen@KeiievDrye.com> Cc: Weiss, Steven <Weiss.Steven@epa.gov>: Keigwin, Richard <Keigwin.Riehard@ep3.gov>; Hughes, Hayley <hughes.hayiev@epa.gov>: Willis, Kristen <Wiliis.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
hebert.iohn@epa.gov
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