#FDAOpenShockDocketsBackUp and #FDAHoldShockDeviceHearings

Thank you 1,990 supporters! Keep Signing! Official Request to FDA Ombudsman Office for More Time to Respond Has Been Submitted The Last 48 hours has shown great strides in receiving support for #FDAStopTheShockDevice. In fact, we received so much support that we need more time to enter all of it into the dockets. Also please see (and share) the video that was made on the most common words used in the comments we received. This email, requesting that the dockets are opened back up, was sent this morning to the FDA Ombudsman Office and the Ombudsman for Medical Devices: This public communication is being published on Facebook, my website, at our petition update, which can be found at: https://www.change.org/p/fda-stop-fda-from-down-classifying-the-shock-device-to-a-class-ii-device-stop-shock-treatment and any other venues that will publish it. Mr. Desta and Ms. Williams, I worked feverishly in attempting to respond to the dockets. Despite this, there was not enough time to respond to both dockets, as we had envisioned. I submitted 675 comments to FDA-2014-N-2010 and not one to FDA-2014-D-1318 as time did not allow. It turns out each comment we received took about 5 minutes or more to format and upload into the docket. We are assembling teams all over the country who are willing to help with data entry. My own comment, littered with typos, was constructed literally at the 11th hour, and submitted at 11:59 PM Eastern. The attachments I attempted to upload, which had the comments of hundreds of people in them (even though not individually inputted into the docket) failed to upload with my comments. As I was at the last moments of attempting to respond, the docket closed before I could do anything more--or even address FDA-2014-D-1318 (although our petition and complaint which was loaded into the docket system based on 674 submissions I entered through MindFreedom International, clearly address both dockets). As a note, of those 674 submissions, there are less than 10 that are duplicate to replace entries that had errors in them. I am not alone in feeling as if there has not been adequate time to comment. People all over the country were unable to meet the deadline. Additionally, those in time zones outside of EST were not prepared to operate outside of their local time, and for this reason many from the central, mountain, and pacific timezones missed the deadline for submitting comments. Further, as we stated in our complaint to you about the processes for participation, we simply did not have enough time to reach people who will be most affected by this proposed rule and guidance. Without media attention, or other types of power, we are just starting to make way into the public sphere, our petition has now been signed by 1,990 people. Please allow us the time, at least until May 4, 2016, which would be 90 business days, not including Federal Holidays from when the proposed rule and guidance was released on December 29, 2016. The closing of the dockets has prevented the voices of hundreds of people, if not thousands of people, from being heard. We are not a trade organization or lobbyists. We are not the people who will profit from making shock devices or subjecting people to shock treatment. Not one of the people involved in our effort to respond to FDA proposed rule and draft guidance was paid for our time in doing so. We are so dedicated to making sure that there is adequate participation from people because we are the people who will be directly subjected--and negatively impacted--by this proposed rule and draft guidance if it is to become order and regulation without our input and proper hearings. To give an idea of what was contained in the comments we received, I used wordle dot net to analyze the comments I received, in terms of word count. The 11 most common words in the comments submitted through the petition, in the order of prevalence are: 1. ECT 2. Treatment 3. people 4. brain 5. shock 6. damage 7. barbaric 8. torture 9. Shock 10. Memory 11. FDA #FDAOpenShockDocketsBackUp and #FDAHoldShockDeviceHearings are two new hashtags that have been started. Here is the video based on that analysis that is going around: https://www.facebook.com/TenneyLauren/videos/10156628115650462/?l=5428316566021365938 I have hope that there will be a quick remedy to this particular issue by re-opening the dockets and allowing the American public to participate in the FDA processes. Please respond to let me know how I can be sure that the comments that were submitted to me through the petition will be heard by FDA. I am attaching materials that I both did submit to the docket FDA-2014-N-2010 and that I was unable to submit to the docket FDA 2014-D-1318 and these include my typo-filled comments to the dockets, the confirmation codes for the comments I attempted to upload and a pdf of all comments submitted through the petition--including more than 50 comments that I did not have enough time to enter into the docket of the proposed rule and none of which were entered into the docket for the proposed guidance. Please let me know that the date for submissions is extended and that the public dockets for comment will be opened back up. As I am writing this I am informed that the comments on 2014-N-2010 are not viewable. My own comment and the 675 comments that I uploaded do not come up in the search. According to "My Comments Page" as a registered MyFR user, it states that not one of the comments has been posted by the agency as of 3/29/2016. I certainly hope this changes! I do hope that we can come to a good result, especially concerning this pressing issue of inadequate time to respond to FDA proposals and release of comments made by people who have been and will be directly impacted by these proposals. Thank you for your time and attention. Lauren (718) 273-8708 (516) 319-4295 Lauren J. Tenney, PhD, MPhil, MPA, Psychiatric Survivor www.LaurenTenney.us